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Clinical Trials/NCT03848728
NCT03848728
Completed
Not Applicable

Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

University of California, San Francisco2 sites in 2 countries1,988 target enrollmentMarch 14, 2019
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of California, San Francisco
Enrollment
1988
Locations
2
Primary Endpoint
Effectiveness of SEARCH Youth Intervention
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2019
End Date
June 23, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Effectiveness of SEARCH Youth Intervention

Time Frame: 2 years

Percentage of study participants with virologic suppression (HIV RNA \<400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)

Study Sites (2)

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