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Community-based Combination HIV Prevention in Tanzanian Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281578
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE November 2, 2014
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date January 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • HIV incidence [ Time Frame: 18 months ]
    Biologic assessment of new infections among HIV-uninfected participants via blood draw
  • Viral load suppression [ Time Frame: 18 months ]
    Biological assessment of viral suppression among HIV-infected participants via blood draw
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • Consistent condom use [ Time Frame: 18 months ]
    Consistent condom use with clients among all participants via survey measures
  • Adherence to ART [ Time Frame: 18 months ]
    Adherence to ART medication among those living with HIV via survey measures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community-based Combination HIV Prevention in Tanzanian Women
Official Title  ICMJE Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk
Brief Summary The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial effectiveness of a community-based combination HIV prevention intervention among bar-based female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase III RCT as warranted.
Detailed Description

Combination HIV prevention demonstrates significant promise in reducing burden of disease. To maximize its effectiveness combination prevention must be tailored to a given context and population. From the beginning of the global HIV epidemic, female sex workers (FSWs) have been found to be at heightened risk for infection. More recently the role that sex work plays in ongoing HIV transmission dynamics has been more clearly established in generalized epidemics, where previously limited attention was paid to the role of key populations. The greater vulnerability of FSWs is now widely understood to be associated with social and structural factors including the intense stigma, discrimination and violence they often face and the unsafe environments in which they live and work. These factors are known to limit both protective sexual behaviors and engagement in HIV testing, care and treatment services. Comprehensive, community-based HIV prevention approaches addressing the aforementioned social and structural vulnerabilities to HIV infection among FSWs have been shown to be effective in South Asia and in Latin America. However, in sub-Saharan Africa where the impact of HIV is the greatest, no systematic efforts to develop and evaluate the feasibility and effectiveness of community-based combination HIV prevention among FSWs has occurred.

The investigators will conduct a two-arm Phase II community randomized controlled trial of a community-based combination HIV prevention intervention among FSWs in Iringa, Tanzania. The model was developed on the basis of prior formative research and mapping and utilizes an ongoing research infrastructure. The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination. The investigators seek to establish base rates of key outcomes including HIV incidence and viral load suppression, examine the socio-structural and behavioral pathways of the intervention, assess feasibility, acceptability and safety, and document preliminary effectiveness. Should compelling indications of safety, feasibility, acceptability and initial effectiveness be found, study results will inform the first Phase III RCT of community-based combination HIV prevention among FSWs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE
  • Behavioral: Community-based combination HIV prevention intervention
    The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination.
  • Behavioral: Standard of care HIV services
    Locally available standard of care HIV prevention, treatment and care services
Study Arms  ICMJE
  • Experimental: Combination prevention
    Community-based, combination HIV prevention intervention package
    Intervention: Behavioral: Community-based combination HIV prevention intervention
  • Active Comparator: Standard of care
    Locally run standard of care HIV prevention, treatment and care services
    Intervention: Behavioral: Standard of care HIV services
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2020)
496
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2014)
500
Actual Study Completion Date  ICMJE January 8, 2018
Actual Primary Completion Date January 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years old, female, exchange sex for money in entertainment venue
  2. key informants working on HIV among sex workers in the region.

Exclusion Criteria:

  • Psychiatric/psychological condition impeding informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281578
Other Study ID Numbers  ICMJE R01MH104044( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE Muhimbili University of Health and Allied Sciences
Investigators  ICMJE
Principal Investigator: Deanna L Kerrigan, PhD, MPH Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP