1 |
NCT03497195 |
Not yet recruiting New |
Achieving Tuberculosis (TB) Control In Zambia |
|
- Diagnostic Test: Screening at community level
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- increase TB case detection
|
26000 |
All |
18 Years and older (Adult, Senior) |
NCT03497195 |
IRB-300001132 |
TB |
May 1, 2018 |
May 1, 2020 |
May 1, 2021 |
April 13, 2018 |
April 13, 2018 |
|
- Center for INfectious Disease resaerch in Zambia (CIDRZ)
Lusaka, Zambia
|
2 |
NCT03373669 |
Recruiting |
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine |
- Cholera
- Vibrio Cholerae Infection
|
- Biological: Oral Cholera Vaccine
- Biological: Adjusted Dose Oral Cholera Vaccine
|
Interventional |
Phase 4 |
- Johns Hopkins Bloomberg School of Public Health
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in Vibriocidal GMT
- Vibriocidal Antibody Response Rates
- Age specific vibriocidal response
- (and 2 more...)
|
120 |
All |
1 Year and older (Child, Adult, Senior) |
NCT03373669 |
IRB00008066 |
|
November 16, 2017 |
August 16, 2018 |
December 1, 2018 |
December 14, 2017 |
December 18, 2017 |
|
- Center for Infectious Disease Research - Zambia
Lusaka, Zambia
|
3 |
NCT03186768 |
Recruiting |
Soap on a Rope Trial |
|
- Behavioral: Soap on a rope hall pass intervention
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Other
|
- Change in hand washing behavior
|
50 |
All |
Child, Adult, Senior |
NCT03186768 |
SoapRopetrial |
|
June 12, 2017 |
September 30, 2017 |
December 31, 2017 |
June 14, 2017 |
October 6, 2017 |
|
- Namwala District
Namwala, Zambia
|
4 |
NCT03174015 |
Active, not recruiting |
Sanitation Demand Creation in Peri-Urban Slums of Lusaka, Zambia |
|
- Behavioral: Bauleni Secret
|
Interventional |
Not Applicable |
- London School of Hygiene and Tropical Medicine
- Centre for Infectious Disease Research in Zambia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Having a hole-cover or water-sealed pan
- Having a latrine door that locks from the inside
- Having a latrine door that locks from the outside
- (and 7 more...)
|
1072 |
All |
18 Years and older (Adult, Senior) |
NCT03174015 |
QA_840 |
SanDem |
August 7, 2017 |
January 2018 |
January 2018 |
June 2, 2017 |
December 8, 2017 |
|
- Bauleni Compound
Lusaka, Zambia
|
5 |
NCT03158844 |
Active, not recruiting |
HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia |
|
|
Observational |
|
- University of Alabama at Birmingham
- University Teaching Hospital
- Centre for Infectious Disease Research in Zambia
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Undetectable HIV viral load at 90 days post-discharge
- Proportion of HIV-infected inpatients who are on ART upon admission
- Mortality rate
- ART initiation
|
315 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03158844 |
F160812007 |
COLAH |
May 16, 2017 |
February 28, 2018 |
June 2018 |
May 18, 2017 |
March 12, 2018 |
|
- University Teaching Hospital
Lusaka, Zambia
|
6 |
NCT03158818 |
Recruiting |
Chronic Hepatitis B Virus Infection in Zambia |
- HBV
- Fibrosis, Liver
- Cirrhosis, Liver
- (and 3 more...)
|
|
Observational |
|
- University of Alabama at Birmingham
- Tropical Gastroenterology and Nutrition Group
- Centre for Infectious Disease Research in Zambia
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
- Proportion of chronic HBV-infected patients with an indication for antiviral treatment.
- HBV viral control among patients on antiviral treatment
- (and 3 more...)
|
500 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03158818 |
F151224005 |
HUTCH |
August 23, 2016 |
January 2021 |
January 2021 |
May 18, 2017 |
May 18, 2017 |
|
- Tropical Gastroenterology and Nutrition Group
Lusaka, Zambia
|
7 |
NCT03149627 |
Recruiting |
Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults |
- HBV
- Alcoholic Hepatitis
- Liver Fibroses
|
- Other: Estimates - prevalence of lifetime/chronic HBV infection
|
Observational |
|
- University of Alabama at Birmingham
- University Teaching Hospital
- Tropical Gastroenterology and Nutrition Group
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence and correlates of lifetime HBV infection
- Proportion of Zambian adults who require antiviral therapy for chronic HBV infection
- Clinical phenotypes of patients with chronic HBV infection
- (and 5 more...)
|
6000 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03149627 |
X160524001 |
HEP-ZED |
June 7, 2017 |
April 2018 |
September 2018 |
May 11, 2017 |
July 2, 2017 |
|
- University Teaching Hospital
Lusaka, Zambia
|
8 |
NCT03141736 |
Not yet recruiting |
Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B) |
- Preterm Birth
- Hypothermia, Newborn
|
- Other: KMC & WHO protocol (0-1 hour)
- Other: KMC, WHO protocol & bag (0-1 hour)
- Other: KMC & WHO protocol (1-24 hours)
- Other: KMC, WHO protocol & bag (1-24 hours)
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
- University Teaching Hospital, Lusaka, Zambia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Moderate or severe hypothermia at 1 hour after birth (Phase 1A)
- Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)
- Any hypothermia at 1 hour after birth (Phase 1A)
- (and 11 more...)
|
420 |
All |
up to 2 Hours (Child) |
NCT03141736 |
F150807004 |
|
May 19, 2019 |
August 12, 2019 |
August 12, 2019 |
May 5, 2017 |
August 21, 2017 |
|
- University Teaching Hospital
Lusaka, Zambia
|
9 |
NCT03141723 |
Completed |
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B) |
- Preterm Infant
- Hypothermia Neonatal
|
- Other: KMC & WHO protocol (0-1 hour)
- Other: KMC, WHO protocol & bag (0-1 hour)
- Other: KMC & WHO protocol (1-24 hours)
- Other: KMC, WHO protocol & bag (1-24 hours)
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
- University Teaching Hospital, Lusaka, Zambia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Moderate or severe hypothermia at 1 hour after birth (Phase 2A)
- Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)
- Any hypothermia at 1 hour after birth (Phase 2A)
- (and 11 more...)
|
420 |
All |
up to 24 Hours (Child) |
NCT03141723 |
F150807003 |
|
May 19, 2017 |
August 12, 2017 |
August 12, 2017 |
May 5, 2017 |
August 21, 2017 |
|
- University Teaching Hospital
Lusaka, Zambia
|
10 |
NCT03134924 |
Completed |
Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2" |
|
- Behavioral: Women's and Sexual Health [WASH]
- Behavioral: Enhanced Standard of Care
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
|
128 |
Female |
18 Years to 60 Years (Adult) |
NCT03134924 |
20120418 |
|
May 3, 2013 |
February 5, 2014 |
February 5, 2014 |
May 1, 2017 |
May 1, 2017 |
|
- University Teaching Hospital
Lusaka, Zambia
|
11 |
NCT02994329 |
Completed |
Community-based Distribution of Oral HIV Self-testing Kits |
|
- Device: OraQuick® HIV Self-Test (Orasure Technologies, Thailand)
|
Interventional |
Not Applicable |
- Zambart
- London School of Hygiene and Tropical Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The proportion of the total resident adult population who know their HIV status
- Proportion of total resident adult population who consent to participate in the intervention
- Proportion of male resident adult population who consent to participate in the intervention
- (and 9 more...)
|
8080 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02994329 |
HIV-SELF 3IE |
|
January 18, 2017 |
September 30, 2017 |
September 30, 2017 |
December 15, 2016 |
January 16, 2018 |
|
|
12 |
NCT02970552 |
Recruiting |
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth |
|
- Drug: Vaginal Progesterone
- Drug: Placebo
|
Interventional |
Phase 4 |
- University of North Carolina, Chapel Hill
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Proportion of women with adequate adherence
- Acceptability of use of VP
- Preliminary efficacy
|
140 |
Female |
18 Years and older (Adult, Senior) |
NCT02970552 |
16-2174 1R21HD090987-01 |
|
July 1, 2017 |
June 2018 |
July 2018 |
November 22, 2016 |
August 24, 2017 |
|
- Kamwala District Health Centre
Lusaka, Zambia
|
13 |
NCT02946762 |
Recruiting |
TasP in Correctional Facilities |
|
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Department for International Development, United Kingdom
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
- Proportion of all HIV-infected inmates starting ART who are retained on ART among those who remain in the study facility
- Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART
- (and 2 more...)
|
6000 |
All |
18 Years and older (Adult, Senior) |
NCT02946762 |
15-1473 |
|
February 1, 2016 |
April 30, 2018 |
December 2018 |
October 27, 2016 |
March 14, 2018 |
|
- Lusaka Central Corrections ART Clinic
Lusaka, Zambia
|
14 |
NCT02941159 |
Recruiting |
SF2000SD Clinical Trial in Zambia |
|
- Biological: SF2000SD
- Biological: Placebo
|
Interventional |
Phase 1 |
- Tropical Diseases Research Centre, Zambia
- National Institute for Scientific and Industrial Research
- University of Zambia
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Proportion of study participants with clinical adverse events such as diarrhea, vomiting, changes in vital signs etc. associated with the test product
- Proportion of study participants with changes in laboratory liver and renal values after administration of test product. These will include ALT, AST, ALP, Total biluribin, Glucose, Urea and Creatinine
- Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells
|
43 |
Male |
18 Years to 45 Years (Adult) |
NCT02941159 |
SF2000SDPh1 |
SF2000SD |
September 2016 |
November 2017 |
February 2018 |
October 21, 2016 |
November 17, 2017 |
|
- Tropical Diseases Resaerch Centre
Ndola, Copperbelt, Zambia
|
15 |
NCT02905162 |
Recruiting |
Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia |
|
- Other: Transitional HIV care for prison releasees
|
Observational |
|
- University of North Carolina, Chapel Hill
- National Institutes of Health (NIH)
- John E. Fogarty International Center (FIC)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of prison releasees retained in care
- Number virologically suppressed
- Change in CD4 count
|
552 |
All |
18 Years and older (Adult, Senior) |
NCT02905162 |
16-0276 1K01TW010272-01 |
|
March 16, 2017 |
September 2018 |
December 2018 |
September 19, 2016 |
March 16, 2018 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
16 |
NCT02866097 |
Recruiting |
Integrated Community Case Management Study in Eastern Province, Zambia |
|
- Other: mHealth inventory management
- Other: Supportive supervision
- Other: ICCM current standard of care
|
Interventional |
Not Applicable |
- Zambia Center for Applied Health Research and Development
- UNICEF
- Bill and Melinda Gates Foundation
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
- a) Medicine availability (artemether-lumefantrine)
- b) Clinical supervision coverage
- (and 6 more...)
|
3840 |
All |
1 Month to 5 Years (Child) |
NCT02866097 |
4980/A0/04/001/010 |
|
March 2016 |
August 2016 |
September 2016 |
August 15, 2016 |
August 15, 2016 |
|
- Chadiza and Chipata Districts
Chipata, Eastern Province, Zambia
|
17 |
NCT02804490 |
Completed |
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status |
|
- Dietary Supplement: Conventional white maize
- Dietary Supplement: Provitamin A carotenoid biofortified maize
- Dietary Supplement: Preformed vitamin A fortified maize
|
Interventional |
Phase 3 |
- Johns Hopkins Bloomberg School of Public Health
- University of California, Davis
- Newcastle University
- HarvestPlus
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Infant vitamin A stores
- Maternal breast milk retinol
- Maternal plasma retinol
- Maternal dark adaptation
|
255 |
Female |
18 Years to 45 Years (Adult) |
NCT02804490 |
2014H8314.JHU |
|
March 2016 |
June 2, 2017 |
June 2, 2017 |
June 17, 2016 |
August 21, 2017 |
|
- JHU Office
Mkushi, Central Province, Zambia
|
18 |
NCT02793804 |
Recruiting |
HIV Self-Testing Africa Zambia |
|
- Device: Oraquick (made in Thailand)
|
Interventional |
Not Applicable |
- London School of Hygiene and Tropical Medicine
- Zambart
- Society for Family Health, Zambia
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report
- Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data
|
4800 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02793804 |
10660 |
STAR Zambia |
June 2016 |
January 31, 2018 |
April 30, 2018 |
June 8, 2016 |
September 21, 2017 |
|
|
19 |
NCT02790827 |
Active, not recruiting |
Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia |
- Domestic Violence
- Mental Health Impairment
- Child Abuse
- Alcoholism
|
- Behavioral: CETA
- Behavioral: Treatment as usual
|
Interventional |
Not Applicable |
- Johns Hopkins Bloomberg School of Public Health
- SHARPZ (Serenity Harm Reduction Programme Zambia)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS)
- Change in alcohol abuse as measured by the Alcohol Use Disorders Identification Test (AUDIT)
- Change in child abuse as measured by the Youth Victimization Scale
- (and 9 more...)
|
626 |
All |
8 Years and older (Child, Adult, Senior) |
NCT02790827 |
IRB00006534 |
|
May 2016 |
December 2018 |
December 2018 |
June 6, 2016 |
January 26, 2018 |
|
- Serenity Harm Reduction Programme Zambia (SHARPZ)
Lusaka, Zambia
|
20 |
NCT02788214 |
Recruiting |
Helicobacter Pylori Genome Project |
- Gastric Cancer
- Non-Atrophic Gastritis
- Intestinal Metaplasia
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
|
2000 |
All |
35 Years to 70 Years (Adult, Senior) |
NCT02788214 |
999916120 16-C-N120 |
|
May 28, 2016 |
December 31, 2018 |
September 30, 2020 |
June 2, 2016 |
April 6, 2018 |
|
- University of Zambia
Lusaka, Zambia
|
21 |
NCT02776254 |
Recruiting |
Differentiated Care for Improved Health Systems Efficiency and Health Outcomes in Zambia |
|
- Other: START
- Other: CAG
- Other: UAG
- Other: FAST-TRACK
|
Interventional |
Not Applicable |
- Centre for Infectious Disease Research in Zambia
- Johns Hopkins University
- University of Alabama at Birmingham
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Retention in care (Time to first missed pharmacy pick-up)
- Feasibility of implementing differentiated care from stakeholder perspectives
- Feasibility of implementing differentiated care based on ART availability
- (and 13 more...)
|
3600 |
All |
15 Years and older (Child, Adult, Senior) |
NCT02776254 |
ID OPP1105306 |
CommART |
March 2016 |
July 2017 |
July 2017 |
May 18, 2016 |
June 20, 2016 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
22 |
NCT02729532 |
Active, not recruiting |
Effect of Xpert MTB/RIF on Patient Outcomes |
|
|
Observational |
|
- University of North Carolina, Chapel Hill
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Culture-positive patient drop-out before accessing treatment
- Time to TB treatment
- Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)
- (and 3 more...)
|
892 |
All |
18 Years and older (Adult, Senior) |
NCT02729532 |
14-1697 US NIH Grant P30 AI50410-17 |
|
June 22, 2016 |
February 28, 2018 |
December 2018 |
April 6, 2016 |
March 12, 2018 |
|
- Chelstone and Chilenje Health Centres
Lusaka, Zambia
|
23 |
NCT02709967 |
Active, not recruiting |
Research Initiative to Support the Empowerment of Girls |
|
- Other: Material support
- Other: Economic
- Behavioral: Community dialogue
|
Interventional |
Not Applicable |
- University of Bergen
- University of Zambia
- Chr. Michelsens Institutt
- Norwegian School of Economics
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of births within 8 months of the end of the intervention
- Incidence of births before girls' 18th birthday
- Proportion of girls who sit for grade 9 exam
- (and 21 more...)
|
5000 |
Female |
9 Years to 25 Years (Child, Adult) |
NCT02709967 |
2015/895 |
RISE |
March 2016 |
December 2020 |
December 2020 |
March 16, 2016 |
November 28, 2016 |
|
- University of Zambia
Lusaka, Zambia
|
24 |
NCT02700269 |
Recruiting |
Vanderbilt-Zambia Innovations in Global Health Technologies |
|
|
Observational |
|
- Macha Research Trust, Zambia
- Vanderbilt University
- National Institutes of Health (NIH)
- John E. Fogarty International Center (FIC)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Enhancement of malaria RDT to detect low levels of P falciparum parasites
|
200 |
All |
6 Months to 85 Years (Child, Adult, Senior) |
NCT02700269 |
MRT15003.2 5D43TW009348 |
VZNIGHT |
April 2016 |
February 2019 |
February 2019 |
March 7, 2016 |
April 3, 2018 |
|
- Macha Research Trust
Choma, Zambia
|
25 |
NCT02688816 |
Completed |
Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia |
|
- Device: Xpert HPV
- Device: OncoE6
|
Observational |
|
- Carla Chibwesha, MD
- National Cancer Institute (NCI)
- University of North Carolina, Chapel Hill
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
- Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified
|
200 |
Female |
18 Years and older (Adult, Senior) |
NCT02688816 |
14-0399 3 D43 CA15378403S1 |
|
August 2014 |
June 2015 |
June 2015 |
February 23, 2016 |
February 23, 2016 |
|
- Adult Infectious Disease Centre at the University Teaching Hospital
Lusaka, Zambia
|
26 |
NCT02661763 |
Completed |
Rheumatic Heart Disease Study in Lusaka |
|
|
Observational |
|
- University of Zambia
- University of Cape Town
- Novartis
|
Other / Industry |
- Observational Model: Ecologic or Community
- Time Perspective: Cross-Sectional
|
- Prevalence of RHD in Lusaka schoolchildren
|
1024 |
All |
10 Years to 21 Years (Child, Adult) |
NCT02661763 |
UNZABREC 002-10-13 |
|
September 2015 |
December 2015 |
December 2015 |
January 22, 2016 |
November 8, 2016 |
|
- University Teaching Hosptial
Lusaka, Zambia
|
27 |
NCT02654912 |
Recruiting |
Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration |
|
- Drug: Reactive Focal Drug Administration
|
Interventional |
Phase 4 |
- PATH
- Ministry of Health, Zambia
- AKROS Global Health
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Malaria seropositivity in children under five
- Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers
- PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months
|
4800 |
All |
3 Months and older (Child, Adult, Senior) |
NCT02654912 |
PATH-WIRB-1155095 |
CORE Zambia |
February 2016 |
June 2018 |
December 2018 |
January 13, 2016 |
April 10, 2018 |
|
- Southern province medical office
Choma, Southern, Zambia
|
28 |
NCT02620436 |
Recruiting |
Impact Evaluation of Maternity Homes Access in Zambia |
|
- Other: Core Mother Shelter Model
|
Interventional |
Not Applicable |
- Boston University
- University of Michigan
- Zambia Center for Applied Health Research and Development
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion of women living more than 10 km from the facility who deliver at a health facility
- C-section rates among women living >10 km away from facility
- Maternal case fatality rate among women living >10 km away from facility
- (and 8 more...)
|
4900 |
Female |
15 Years and older (Child, Adult, Senior) |
NCT02620436 |
H34526 |
MAHMAZ |
March 2016 |
May 2018 |
May 2018 |
December 3, 2015 |
June 5, 2017 |
|
|
29 |
NCT02612896 |
Recruiting |
Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa? |
|
- Drug: Mass drug administration, praziquantel 10mg/kg
- Behavioral: Health education
|
Interventional |
Not Applicable |
- Institute of Tropical Medicine, Belgium
- University of Zambia
- Ministry of Health, Zambia
- (and 2 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Other
|
- Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
- Change in human cysticercosis active infection (serum: )
- Change in human cysticercosis, exposure to infection (serum)
- Change in human taeniasis (stool)
|
2900 |
All |
5 Years and older (Child, Adult, Senior) |
NCT02612896 |
CYSTISTOP_2.2_07012016 |
CYSTISTOP |
March 2016 |
September 2020 |
November 2020 |
November 24, 2015 |
July 28, 2017 |
|
- Nyembe and Mtandaza Rural Health Centre
Katete District, Eastern Province, Zambia
|
30 |
NCT02573623 |
Unknown † |
Evaluation of an Innovative Tuberculosis Diagnostic Test |
|
|
Observational |
|
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- European and Developing Countries Clinical Trials Partnership (EDCTP)
|
Other |
- Time Perspective: Prospective
|
- Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
- Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
|
300 |
All |
up to 15 Years (Child) |
NCT02573623 |
ANRS12293 PROMISE-TB |
PROMISE-TB |
July 2013 |
October 2015 |
December 2015 |
October 12, 2015 |
October 12, 2015 |
|
- Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
Lusaka, Zambia
|
31 |
NCT02516852 |
Completed |
Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia |
- Malnutrition, Child
- Malnutrition, Infant
|
|
Interventional |
Not Applicable |
- Cornell University
- Community Markets for Conservation (COMACO)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in child height-for-age Z-score
- Change in household egg consumption
- Change in maternal egg consumption
- (and 4 more...)
|
3546 |
All |
6 Months to 36 Months (Child) |
NCT02516852 |
1402004456 |
|
June 2014 |
July 2016 |
May 2017 |
August 6, 2015 |
February 6, 2018 |
|
- COMACO
Mfuwe, Eastern Province, Zambia
|
32 |
NCT02459678 |
Recruiting |
ART Readiness in HIV-infected Pregnant Women |
- Human Immunodeficiency Virus
|
- Behavioral: Enhanced Adherence Package
- Other: Standard of Care
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Centre for Infectious Disease Research in Zambia
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion of women who both initiate ART and are retained in care
- HIV virologic suppression at time of delivery
- Time from ART eligibility to ART initiation
- HIV transmission from mother to infant
|
526 |
All |
18 Years and older (Adult, Senior) |
NCT02459678 |
13-3884 |
|
May 2015 |
December 2017 |
January 2018 |
June 2, 2015 |
June 28, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
33 |
NCT02445846 |
Completed |
Dual Rapid HIV & Syphilis Tests in Zambia |
|
- Device: dual HIV/syphilis rapid diagnostics tests
|
Observational |
|
- University of North Carolina, Chapel Hill
- World Health Organization
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- performance of dual rapid HIV/syphilis tests
- acceptability of use of dual rapid HIV/syphilis tests
|
3010 |
Female |
18 Years and older (Adult, Senior) |
NCT02445846 |
14-0528 |
|
May 2014 |
December 2015 |
January 2016 |
May 15, 2015 |
April 21, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
34 |
NCT02394522 |
Withdrawn |
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Zambia (SR-M-ZM) |
|
- Device: Spatial Repellent product with active ingredient (SHIELD)
- Device: Active Ingredient
- Device: Spatial Repellent product without active ingredient (SHIELD)
|
Interventional |
Not Applicable |
- University of Notre Dame
- Ministry of Health, Zambia
- Macha Research Trust, Zambia
- Johns Hopkins University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
|
0 |
All |
6 Months to 59 Months (Child) |
NCT02394522 |
SR-M-Zm |
SR-M-ZM |
March 2016 |
April 2016 |
April 2016 |
March 20, 2015 |
October 6, 2016 |
|
- Macha Research Trust
Macha, Choma, Zambia
|
35 |
NCT02386592 |
Completed |
Prevention of Nosocomial Bacteremia Among Zambian Neonates |
- Neonatal Sepsis
- Neonatal Mortality
|
- Drug: Chlorhexidine gluconate (CHG)
- Behavioral: Hand hygiene (HH)
- Behavioral: Infection control training
- Other: Infection control reminders via SMS text
|
Interventional |
Not Applicable |
- Boston University
- University Teaching Hospital, Lusaka, Zambia
- Zambia Center for Applied Health Research and Development
- Children's Hospital of Philadelphia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- All-cause neonatal mortality in hospitalized neonates
- Incidence of nosocomial bacteremia in hospitalized neonates
- Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates
- Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates
|
9410 |
All |
up to 28 Days (Child) |
NCT02386592 |
H-33473 |
|
September 1, 2015 |
April 15, 2017 |
July 2017 |
March 12, 2015 |
July 31, 2017 |
|
- University Teaching Hospital
Lusaka, Zambia
|
36 |
NCT02344680 |
Recruiting |
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients |
- Human Immunodeficiency Virus
- HBV
- Fibrosis, Liver
- (and 4 more...)
|
|
Observational |
|
- University of Alabama at Birmingham
- John E. Fogarty International Center (FIC)
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in liver fibrosis stage
- Incidence of hepatocellular carcinoma
- Prevalence of significant liver fibrosis (Metavir F2 or greater)
- Risk factors for persistent HBV viremia 9Measure HBV DNA at baseline and month 12 and determine patient characteristics associated with unsuppressed HBV after 12 months of treatment)
|
400 |
All |
18 Years and older (Adult, Senior) |
NCT02344680 |
F150819001 1K01TW009998 |
|
October 2015 |
December 2018 |
December 2018 |
January 26, 2015 |
May 24, 2017 |
|
- Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia
|
37 |
NCT02329301 |
Active, not recruiting |
Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia |
- Malaria
- Malaria, Falciparum
|
- Drug: MDA with DHAp (Eurartesim)
- Drug: Focal MDA with DHAp (Eurartesim)
|
Interventional |
Not Applicable |
- PATH
- Ministry of Health, Zambia
- Minister of Community Development, Mother and Child Health, Zambia
- Tulane University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
- P.falciparum infection incidence rate among individuals ≥3 months
- Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
- Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group)
|
2430 |
All |
3 Months and older (Child, Adult, Senior) |
NCT02329301 |
PATH-WIRB-20140824 |
|
September 2014 |
June 2016 |
March 2018 |
December 31, 2014 |
September 21, 2017 |
|
- Southern province medical office
Choma, Southern, Zambia
|
38 |
NCT02242539 |
Completed |
Tools to Improve Parental Recognition of Developmental Deficits in Children |
- Malnutrition
- Child Development
|
- Behavioral: Height measurement poster
- Behavioral: Community-based monitoring
|
Interventional |
Not Applicable |
- Boston University
- Harvard University
- Innovations for Poverty Action
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Height-for-age z-score
- Child development outcomes
- Mid-upper arm circumference (MUAC)
- Dietary intake
|
547 |
All |
6 Months to 18 Months (Child) |
NCT02242539 |
14-2948 |
|
September 2014 |
September 2015 |
September 2015 |
September 17, 2014 |
January 13, 2016 |
|
- Household sample
Chipata District, Zambia
|
39 |
NCT02189759 |
Completed Has Results |
Kangaroo Mother Care to Prevent Hypothermia in Term Infants |
|
- Other: Continuous Kangaroo Mother Care to one hour after birth
- Other: Standard Kangaroo Mother Care to one hour after birth
- Other: Continuous Kangaroo Mother Care to discharge
- Other: Standard Kangaroo Mother Care to discharge
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Infants With Axillary Temperature <36.0 Degrees Celsius
- Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge
- Number Infants Admitted to the Neonatal Intensive Care Unit
- Duration of Kangaroo Mother Care
|
375 |
All |
up to 2 Weeks (Child) |
NCT02189759 |
UAB Neo 012 |
|
August 2014 |
September 2014 |
September 2014 |
July 15, 2014 |
June 19, 2017 |
June 19, 2017 |
- University Teaching Hospital
Lusaka, Zambia
|
40 |
NCT02189746 |
Completed |
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants |
|
- Other: Continuous Kangaroo Mother Care to 1 hour after birth
- Other: Standard Kangaroo Mother Care to 1 hour after birth
- Other: Continuous Kangaroo Mother Care to discharge
- Other: Standard Kangaroo Mother Care to discharge
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Axillary temperature < 36.0 degrees Celsius
- Axillary Temperature < 36.0 degrees Celsius
- Blood pressure
- (and 8 more...)
|
140 |
All |
up to 8 Weeks (Child) |
NCT02189746 |
UAB Neo 011 |
|
June 2014 |
August 2017 |
August 2017 |
July 15, 2014 |
January 10, 2018 |
|
- University Teaching Hospital
Lusaka, Zambia
|
41 |
NCT02081521 |
Completed |
Evaluation of a Multiple Behaviour Programme for Diarrhoea Management |
|
- Behavioral: Community behaviour change campaign
|
Interventional |
Not Applicable |
- London School of Hygiene and Tropical Medicine
- Centre for Infectious Disease Research in Zambia
- Absolute Return for Kids
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in target behaviour: zinc use
- Change in target behaviour: correct ORS preparation
- Change in target behaviour: Exclusive breastfeeding
- (and 9 more...)
|
640 |
All |
1 Month to 59 Months (Child) |
NCT02081521 |
QA511 |
|
January 2014 |
November 2014 |
November 2014 |
March 7, 2014 |
March 11, 2016 |
|
- Centre for Infectious Disease Research Zambia
Lusaka, Lusaka Province, Zambia
|
42 |
NCT02060162 |
Active, not recruiting |
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa |
- Hepatitis B Virus
- HIV
- Antiretroviral Therapy
- (and 3 more...)
|
|
Observational |
|
- University of Alabama at Birmingham
- Centre for Infectious Disease Research in Zambia
- University of Bern
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Immunological response
- HIV virological response
- Mortality
- (and 6 more...)
|
900 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02060162 |
F160229001 |
|
October 2013 |
June 2021 |
June 2021 |
February 11, 2014 |
May 24, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
43 |
NCT02058927 |
Completed |
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia |
|
|
Observational |
|
- University of North Carolina, Chapel Hill
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Memory immune responses to measles virus
- Humoral and cellular immune responses to measles virus before and after revaccination
|
203 |
All |
9 Months to 10 Years (Child) |
NCT02058927 |
CIDRZ 1204/IRB12-0400 R01AI070018 |
|
May 2011 |
February 2012 |
February 2012 |
February 10, 2014 |
September 18, 2014 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
44 |
NCT02054780 |
Completed |
Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being |
- Risk Behavior
- Mental Health Impairment
|
- Behavioral: Trauma-Focused Cognitive Behavioral Therapy
- Behavioral: Psychosocial Counseling
|
Interventional |
Not Applicable |
- Johns Hopkins Bloomberg School of Public Health
- SHARPZ (Serenity Harm Reduction Programme Zambia)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in HIV Risk Behavior as measured by the World Aids Foundation (WAF) survey
- Change in Mental Health and Well-being
- Change in Caregiver mental health and well-being
- Cost Effectiveness of TF-CBT and PC
|
610 |
All |
13 Years to 17 Years (Child) |
NCT02054780 |
5R01HD070720 |
|
February 2014 |
November 2017 |
November 2017 |
February 4, 2014 |
April 5, 2018 |
|
- Serenity Harm Reduction Programme Zambia (SHARPZ)
Lusaka, Zambia
|
45 |
NCT02053142 |
Completed |
Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women |
- Ulcers of Female Genital Organs
|
- Drug: Acyclovir
- Drug: Placebo
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Area under the Curve (AUC)
- Time to re-epithelization and time to cessation of HSV shedding
|
74 |
Female |
18 Years to 50 Years (Adult) |
NCT02053142 |
CIDRZ 1208/IRB12-0390 |
|
January 2009 |
December 2009 |
December 2009 |
February 3, 2014 |
September 15, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
46 |
NCT02053129 |
Completed |
Evaluation of PTB Screening in ANC in Lusaka, Zambia |
|
- Other: TB screening Questionnaire
- Other: Sputum smear and culture (only in HIV negative women who are symptomatic)
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Centre for Infectious Disease Research in Zambia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- number of positive pulmonary tuberculosis (PTB) tests
- Sensitivity and specificity of symptom-based TB screening
|
5033 |
Female |
18 Years to 99 Years (Adult, Senior) |
NCT02053129 |
CIDRZ 1217/IRB12-0417 |
|
November 2011 |
October 2012 |
December 2013 |
February 3, 2014 |
September 15, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
47 |
NCT02043080 |
Completed |
Optimizing Clinical Outcomes in HIV-Infected Adults & Children |
- Tuberculosis Diagnosis
- HIV
|
- Other: Xpert MTB/RIF Tuberculosis diagnostic tool
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase
- Clinical outcomes of subjects screened using the Xpert MTB/RIF algorithm compared to existing standard of care.
|
1436 |
All |
up to 99 Years (Child, Adult, Senior) |
NCT02043080 |
12-1402 |
|
August 2012 |
March 2016 |
April 2017 |
January 23, 2014 |
August 3, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
48 |
NCT02043067 |
Completed |
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV |
|
- Other: Comprehensive TB screening
|
Observational |
|
- University of North Carolina, Chapel Hill
- Centre for Infectious Disease Research in Zambia
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of undiagnosed TB in those with HIV.
- Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
|
400 |
All |
16 Years to 99 Years (Child, Adult, Senior) |
NCT02043067 |
CIDRZ 1226/IRB12-0416 |
|
October 2011 |
September 2012 |
May 2013 |
January 23, 2014 |
September 15, 2017 |
|
- Kalingalinga HIV Care and Treatment Clinic
Lusaka, Zambia
|
49 |
NCT02012816 |
Completed |
The Use of Peer Referral Incentives to Increase Demand for Voluntary Medical Male Circumcision in Zambia |
|
- Other: Peer‐referral incentive program to increase VMMC uptake
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- Centers for Disease Control and Prevention
- Centre for Infectious Disease Research in Zambia
|
Other / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Primary outcome will be the number of men coming for circumcision in each clinic during the intervention period divided by the adult male population in the catchment area of each clinic.
|
725 |
Male |
18 Years to 49 Years (Adult) |
NCT02012816 |
CIDRZ 1310 |
|
June 2014 |
September 2015 |
November 2015 |
December 16, 2013 |
June 6, 2016 |
|
- Center for Infectious Disease Research in Zambia
Lusaka, Zambia
|
50 |
NCT01951794 |
Completed |
Validation of a Community Survey Methodology for Measuring PMTCT Program Impact |
|
|
Observational |
|
- University of North Carolina, Chapel Hill
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Ecologic or Community
- Time Perspective: Cross-Sectional
|
- HIV-free survival among HIV-exposed infants.
|
827 |
All |
up to 49 Years (Child, Adult) |
NCT01951794 |
CIDRZ 1225 R01HD075131-01 |
|
June 2014 |
November 2016 |
December 2016 |
September 27, 2013 |
April 19, 2017 |
|
- Centre for Infectious Disease Reseach in Zambia
Lusaka, Zambia
|