Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

HIV Clinical Trial

Official title:

Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848728
• Other study ID #: SEARCH Youth
• Secondary ID: UG3HD096915UH3HD
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: June 23, 2023

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2069
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• SEARCH Youth combination intervention
Administration of life-stage assessment tool Structured choice clinic access Rapid feedback of VL results Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information

Locations

Country	Name	City	State
Kenya	Western Kenya	Sindo
Uganda	Southwestern Uganda	Mbarara

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University

Countries where clinical trial is conducted

Kenya,  Uganda, 

References & Publications (6)

Evans D, Menezes C, Mahomed K, Macdonald P, Untiedt S, Levin L, Jaffray I, Bhana N, Firnhaber C, Maskew M. Treatment outcomes of HIV-infected adolescents attending public-sector HIV clinics across Gauteng and Mpumalanga, South Africa. AIDS Res Hum Retroviruses. 2013 Jun;29(6):892-900. doi: 10.1089/AID.2012.0215. Epub 2013 Feb 25. — View Citation

Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015. — View Citation

Lamb MR, Fayorsey R, Nuwagaba-Biribonwoha H, Viola V, Mutabazi V, Alwar T, Casalini C, Elul B. High attrition before and after ART initiation among youth (15-24 years of age) enrolled in HIV care. AIDS. 2014 Feb 20;28(4):559-68. doi: 10.1097/QAD.0000000000000054. — View Citation

Massaquoi M, Zachariah R, Manzi M, Pasulani O, Misindi D, Mwagomba B, Bauernfeind A, Harries AD. Patient retention and attrition on antiretroviral treatment at district level in rural Malawi. Trans R Soc Trop Med Hyg. 2009 Jun;103(6):594-600. doi: 10.1016/j.trstmh.2009.02.012. Epub 2009 Mar 18. — View Citation

Nachega JB, Hislop M, Nguyen H, Dowdy DW, Chaisson RE, Regensberg L, Cotton M, Maartens G. Antiretroviral therapy adherence, virologic and immunologic outcomes in adolescents compared with adults in southern Africa. J Acquir Immune Defic Syndr. 2009 May 1;51(1):65-71. doi: 10.1097/QAI.0b013e318199072e. — View Citation

Zurcher K, Mooser A, Anderegg N, Tymejczyk O, Couvillon MJ, Nash D, Egger M; IeDEA and MESH consortia. Outcomes of HIV-positive patients lost to follow-up in African treatment programmes. Trop Med Int Health. 2017 Apr;22(4):375-387. doi: 10.1111/tmi.12843. Epub 2017 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of SEARCH Youth intervention	Proportion of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up	2 years