Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

NCT03848728 | Completed Results DMC

• 3 other identifiers: SEARCH YouthUG3HD096915UH3HD096915
• Study Type: interventional
• Target: 1,988
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; Adolescent; Young Adult; Viral Load; Counseling; Costs and Cost Analysis

Outcome Measures

Primary Outcomes (1)

• Effectiveness of SEARCH Youth Intervention

  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)

  2 years

Study Arms (2)

Intervention Clinics

EXPERIMENTAL

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

Control Clinics

NO INTERVENTION

Optimized country standard of care

Interventions

SEARCH Youth combination intervention 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

Intervention Clinics

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Kenya Medical Research Institute: collaborator
• Makerere University: collaborator

Study Sites (2)

Western Kenya

Sindo, Kenya

Location

Southwestern Uganda

Mbarara, Uganda

Location

Related Publications (9)

• 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.

  PMID: 24076661 BACKGROUND

• 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.

  PMID: 23373540 BACKGROUND

• 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.

  PMID: 19282780 BACKGROUND

• 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.

  PMID: 25695494 BACKGROUND

• 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.

  PMID: 28102610 BACKGROUND

• 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.

  PMID: 19298993 BACKGROUND

• 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.

  PMID: 37541706 DERIVED

• 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.

  PMID: 35818888 DERIVED

• 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.

  PMID: 35578398 DERIVED

Results Point of Contact

• Title: Douglas Black
• Organization: University of California, San Francisco

douglas.black@ucsf.edu

4158063016

Study Officials

• Diane V Havlir, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Moses R Kamya, MBChB, MMed, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized trial

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: March 14, 2019
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); KE (1)