Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995953
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Population Council
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
RTI International

Brief Summary:
The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented with 6 geographic regions randomized into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. HIV testing will be assessed among the SHIELD only HIV negative or unknown (HIV-/u) cohort and retention in care along with viral load suppression will be primarily assessed in the IWC clinics and SHIELD HIV positive (HIV+) cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback following the trial. Cost-effectiveness of the interventions and budgetary impacts will be assessed through using a cost assessment tool.

Condition or disease Intervention/treatment Phase
HIV Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) Other: Integrated wellness care (IWC) clinics Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Zones, with their respective clinics, will be randomized into three groups (zones with integrated wellness care (IWC) clinics and (Support for HIV Integrated Education, Linkages to care, and Destigmatization) SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention at the clinic or community levels) to assess the impact of offering IWC clinics coupled with the SHIELD intervention compared to the standard of care. In each clinic zone, the study team will use stratified random sampling, using age-group strata drawn from the sampling frame previously established, to select AGYW for the HIV-/u and HIV+ study cohorts. The sample size was calculated assuming conventional specifications (power = .80, alpha = .05, two-sided tests) and based on the primary endpoints.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in Zambia
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
2 control zones with no intervention at the clinic or community level
Experimental: SHIELD: Community-based behavioral intervention
2 clinic zones where participants attend modules designed to educate and empower adolescent girls and young women (AGYWs) and their families, along with attendance at community-based youth clubs to foster peer support.
Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)
The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for family members to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.

Experimental: SHIELD: Community- based behavioral intervention & IWC Clinic
2 clinic zones where participants receive the Support for HIV Integrated Education, Linkages to care, and Destigmatization (SHIELD) intervention along with the coupled benefits of having an integrated wellness care (IWC) clinic within health facilities where adolescent girls and young women (AGYWs) can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and human papilloma virus (HPV) vaccination.
Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)
The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for family members to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.

Other: Integrated wellness care (IWC) clinics
IWC clinics will be created within health facilities where AGYWs can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and HPV vaccination in a youth-friendly environment.




Primary Outcome Measures :
  1. HIV testing [ Time Frame: 6 months ]
    HIV-/u cohort proportion tested for HIV in the past 6 months

  2. HIV testing [ Time Frame: 12 months ]
    HIV-/u cohort proportion tested for HIV in the past 12 months

  3. Retention in care [ Time Frame: 12 months ]
    HIV+ cohort proportion with at least one visit during the 12-months follow-up

  4. Viral load suppression [ Time Frame: 12 months ]
    HIV+ cohort proportion with undetectable viral load at 12 months


Secondary Outcome Measures :
  1. HIV risk behavior - delay in first intercourse [ Time Frame: Baseline ]
    HIV -/u proportion with delay in first intercourse self-report

  2. HIV risk behavior - delay in first intercourse [ Time Frame: 6 months ]
    HIV -/u proportion with delay in first intercourse self-report

  3. HIV risk behavior - delay in first intercourse [ Time Frame: 12 months ]
    HIV -/u proportion with delay in first intercourse self-report

  4. HIV risk behavior - reduction in sexual partners [ Time Frame: Baseline ]
    HIV -/u reduction in sexual partners self-report

  5. HIV risk behavior - reduction in sexual partners [ Time Frame: 6 months ]
    HIV -/u reduction in sexual partners self-report

  6. HIV risk behavior - reduction in sexual partners [ Time Frame: 12 months ]
    HIV -/u reduction in sexual partners self-report

  7. HIV risk behavior - increases in condom use [ Time Frame: Baseline ]
    HIV -/u increases in condom use self-report

  8. HIV risk behavior - increases in condom use [ Time Frame: 6 months ]
    HIV -/u increases in condom use self-report

  9. HIV risk behavior - increases in condom use [ Time Frame: 12 months ]
    HIV -/u increases in condom use self-report

  10. HIV early detection [ Time Frame: 12 months ]
    HIV-/u proportion with HIV identified through voluntary testing

  11. Linkages to HIV care - enrollment at HIV clinic [ Time Frame: 6 months ]
    Proportion enrolled at an HIV clinic in ≤ 30 days

  12. Linkages to HIV care - enrollment at HIV clinic [ Time Frame: 12 months ]
    Proportion enrolled at an HIV clinic in ≤ 30 days

  13. Linkages to HIV care - ART initiation [ Time Frame: 6 months ]
    Proportion with ART initiated in ≤ 90 days

  14. Linkages to HIV care - ART initiation [ Time Frame: 12 months ]
    Proportion with ART initiated in ≤ 90 days

  15. Adherence to ART [ Time Frame: 6 months ]
    HIV+ proportion filling prescriptions at least every 3 months

  16. Adherence to ART [ Time Frame: 12 months ]
    HIV+ proportion filling prescriptions at least every 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adolescent girls and young women. Not based on self-representation of gender identity.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

HIV negative or unknown cohort

  • Female
  • 10 to 20 years of age
  • self-report HIV status as negative or unknown (no HIV testing within the past 6 months
  • not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
  • is willing to sign a release for medical records (to obtain clinic data on service use)
  • plans to reside in the current location for the next 18 months
  • has not been part of the other planned formative research activities

HIV positive cohort

  • Female
  • 16 to 24 years of age
  • diagnosed with HIV within the past 3 years or newly diagnosed at the time of the study
  • not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
  • is willing to sign a release for medical records (to obtain clinic data on service use)
  • plans to reside in the current location for the next 18 months
  • has not been part of the other planned formative research activities

Exclusion Criteria:

  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995953


Contacts
Layout table for location contacts
Contact: Sujha Subramanian, PhD 781-434-1749 ssubramanian@rti.org

Locations
Layout table for location information
Zambia
Population Council
Lusaka, Zambia
Contact: Michael Mbizvo, PhD    +260 211 295 925    mmbizvo@popcouncil.org   
Sub-Investigator: Michael Mbizvo, PhD         
Sub-Investigator: Carla Chibwesha, MD         
Sub-Investigator: Maurice Musheke, PhD         
Principal Investigator: Sujha Subramanian, PhD         
Sponsors and Collaborators
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Population Council
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Principal Investigator: Sujha Subramanian, PhD RTI International

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT03995953    
Other Study ID Numbers: 1UG3HD096908-01 ( U.S. NIH Grant/Contract )
1UG3HD096908-01 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of the study, the data will be placed in an NIH electronic database that could be used by researchers outside our study team who are interested in using it to answer questions about access to youth-friendly health services in Zambia. Responses will be inputted after they have been stripped of identifiers such as name, so that it may be used and shared for future research.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
HIV prevention
HIV treatment
Zambia