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Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

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ClinicalTrials.gov Identifier: NCT03848728
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Infectious Diseases Research Collaboration, Uganda
Kenya Medical Research Institute
Makerere University
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Other: SEARCH Youth combination intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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
No Intervention: Control Clinics
Optimized country standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of SEARCH Youth intervention [ Time Frame: 2 years ]
    Proportion of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848728


Contacts
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Contact: Diane V Havlir, MD 415-476-4082 ext 400 diane.havlir@ucsf.edu
Contact: Moses R Kamya, MBChB, MMed, PhD +256-312-281479 mkamya@idrc-uganda.org

Locations
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Kenya
Western Kenya Recruiting
Sindo, Kenya
Contact: Elizabeth Bukusi, MBChB, M.Med, MPH, PhD    +254-733-617503    ebukusi@rctp.or.ke   
Principal Investigator: Elizabeth Bukusi, MBChB, M.Med, MPH, PhD         
Uganda
Southwestern Uganda Recruiting
Mbarara, Uganda
Contact: Moses R Kamya, MBChB, MMed, PhD    +256-312-281479    mkamya@idrc-uganda.org   
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD         
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Diane V Havlir, MD University of California, San Francisco
Principal Investigator: Moses R Kamya, MBChB, MMed, PhD Makerere University
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03848728    
Other Study ID Numbers: SEARCH Youth
UG3HD096915 ( U.S. NIH Grant/Contract )
UH3HD096915 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
HIV
Adolescent
Young Adult
 Viral Load
Counseling
Costs and Cost Analysis