Clinical trial NCT03848728: Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
Official title: Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Adolescent
Young Adult
Viral Load
Counseling
Costs and Cost Analysis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Infectious Diseases Research Collaboration, Uganda
name: Kenya Medical Research Institute
name: Makerere University
First posted: 2019-02-21
Enrollment: 1988
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

* None

Primary outcomes:
measure: Effectiveness of SEARCH Youth Intervention
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sindo
country: Kenya
facility: Western Kenya
city: Mbarara
country: Uganda
facility: Southwestern Uganda
Study officials:
affiliation: University of California, San Francisco
name: Diane V Havlir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Moses R Kamya, MBChB, MMed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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