Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

NCT ID: NCT03848728

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1988 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2023-06-23

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SEARCH Youth combination intervention

Intervention Type: OTHER

• 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

Control Clinics

Optimized country standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diane V Havlir, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Moses R Kamya, MBChB, MMed, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Locations

Western Kenya

Sindo, , Kenya

Southwestern Uganda

Mbarara, , Uganda

Countries

Kenya; Uganda

References

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.

Reference Type: BACKGROUND

PMID: 24076661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23373540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19282780 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25695494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28102610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19298993 (View on PubMed)

Ruel T, Mwangwa F, Balzer LB, Ayieko J, Nyabuti M, Mugoma WE, Kabami J, Kamugisha B, Black D, Nzarubara B, Opel F, Schrom J, Agengo G, Nakigudde J, Atuhaire HN, Schwab J, Peng J, Camlin C, Shade SB, Bukusi E, Kapogiannis BG, Charlebois E, Kamya MR, Havlir D. A multilevel health system intervention for virological suppression in adolescents and young adults living with HIV in rural Kenya and Uganda (SEARCH-Youth): a cluster randomised trial. Lancet HIV. 2023 Aug;10(8):e518-e527. doi: 10.1016/S2352-3018(23)00118-2.

Reference Type: DERIVED

PMID: 37541706 (View on PubMed)

Johnson-Peretz J, Lebu S, Akatukwasa C, Getahun M, Ruel T, Lee J, Ayieko J, Mwangwa F, Owino L, Onyango A, Maeri I, Atwine F, Charlebois ED, Bukusi EA, Kamya MR, Havlir DV, Camlin CS. "I was still very young": agency, stigma and HIV care strategies at school, baseline results of a qualitative study among youth in rural Kenya and Uganda. J Int AIDS Soc. 2022 Jul;25 Suppl 1(Suppl 1):e25919. doi: 10.1002/jia2.25919.

Reference Type: DERIVED

PMID: 35818888 (View on PubMed)

Mwangwa F, Charlebois ED, Ayieko J, Olio W, Black D, Peng J, Kwarisiima D, Kabami J, Balzer LB, Petersen ML, Kapogiannis B, Kamya MR, Havlir DV, Ruel TD. Two or more significant life-events in 6-months are associated with lower rates of HIV treatment and virologic suppression among youth with HIV in Uganda and Kenya. AIDS Care. 2023 Jan;35(1):95-105. doi: 10.1080/09540121.2022.2052260. Epub 2022 May 16.

Reference Type: DERIVED

PMID: 35578398 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UG3HD096915

Identifier Type: NIH

Identifier Source: secondary_id

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UH3HD096915

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SEARCH Youth

Identifier Type: -

Identifier Source: org_study_id