Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
![]() |
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: NCT03848728 |
Recruitment Status :
Recruiting
First Posted : February 21, 2019
Last Update Posted : August 3, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Other: SEARCH Youth combination intervention | Not Applicable |
The randomized controlled trial (RCT) will evaluate the effect of the SEARCH Youth intervention on long-term HIV viral load suppression among HIV-infected adolescents/young adults. The study's intervention is based on the PRECEDE model of behavioral change that is targeted towards adolescent and young adult behavior. The study design is a cluster-randomized trial where the unit of randomization is the HIV clinic: 14 clinics randomized to the intervention and 14 to the optimized country standard of care (Differentiated ART care, standard clinic hours, routine VL monitoring, access to 2nd and 3rd line ART), balanced within country. The target enrollment for the intervention is approximately 2300 (50-100 adolescents/young adults with HIV in each clinic, plus family members, providers and others taking part in qualitative interviews).
Community-tailored youth testing and linkage strategies for ART will be implemented to recruit youth for the SEARCH Youth combination intervention RCT. Strategies to reach youth at the highest risk of HIV infection will be implemented. Those individuals who test HIV-positive will be referred to the local clinic for HIV treatment services and, if they otherwise meet entry criteria, to the SEARCH Youth study for possible inclusion.
The components of the SEARCH Youth intervention include:
- Administration of life-stage assessment tool at the beginning of each visit that links to life-stage specific actions and puts subsequent medical discussions into an appropriate context
- Structured choice clinic access which will provide a choice to schedule visits during or after routine clinic hours or in an alternate location, with some phone-only visits available between in-person visits
- Rapid feedback of VL results, by phone or in person, aiming to be provided within 72 hours, to provide immediate feedback on HIV suppression and engage participants in their overall health
- Provider e-collaboratives that comprises of chat groups using WhatsApp or similar secure messaging applications to solicit input about challenging cases using de-identified information
Participants will take part in the study for at least 2 years.
Some participants, family members, providers, HIV-negative youth and key informants will also take part in qualitative interview guides. Costs of the SEARCH Youth intervention will be evaluated to assess its efficiency and cost-effectiveness including as cost per participant, cost per additional participant with viral suppression and cost per DALY gained.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster-randomized trial |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa |
Actual Study Start Date : | March 14, 2019 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention Clinics
SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers
|
Other: SEARCH Youth combination intervention
|
No Intervention: Control Clinics
Optimized country standard of care
|
- Effectiveness of SEARCH Youth intervention [ Time Frame: 2 years ]Proportion of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up

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.
Ages Eligible for Study: | 15 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infection diagnosed according to country testing guidelines
- Age 15-24 years
- Enrolled in care in a study clinic
- Ability and willingness to provide informed consent
Exclusion Criteria:
- None

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): NCT03848728
Contact: Diane V Havlir, MD | 415-476-4082 ext 400 | diane.havlir@ucsf.edu | |
Contact: Moses R Kamya, MBChB, MMed, PhD | +256-312-281479 | mkamya@idrc-uganda.org |
Kenya | |
Western Kenya | Recruiting |
Sindo, Kenya | |
Contact: Elizabeth Bukusi, MBChB, M.Med, MPH, PhD +254-733-617503 ebukusi@rctp.or.ke | |
Principal Investigator: Elizabeth Bukusi, MBChB, M.Med, MPH, PhD | |
Uganda | |
Southwestern Uganda | Recruiting |
Mbarara, Uganda | |
Contact: Moses R Kamya, MBChB, MMed, PhD +256-312-281479 mkamya@idrc-uganda.org | |
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD |
Principal Investigator: | Diane V Havlir, MD | University of California, San Francisco | |
Principal Investigator: | Moses R Kamya, MBChB, MMed, PhD | Makerere University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03848728 |
Other Study ID Numbers: |
SEARCH Youth UG3HD096915 ( U.S. NIH Grant/Contract ) UH3HD096915 ( U.S. NIH Grant/Contract ) |
First Posted: | February 21, 2019 Key Record Dates |
Last Update Posted: | August 3, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Adolescent Young Adult |
Viral Load Counseling Costs and Cost Analysis |