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Clinical Trials/NCT03751826
NCT03751826
Unknown
Not Applicable

Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa: A Cluster Randomized Control Trial

University College, London0 sites2,000 target enrollmentJanuary 14, 2019
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University College, London
Enrollment
2000
Primary Endpoint
The rate of linkage among women ages 18-24 years to HIV prevention services.
Last Updated
7 years ago

Overview

Brief Summary

Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.

Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa.

Objectives:

  1. To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
  2. To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
  3. To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
  4. To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.

Primary Outcomes:

The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.

Registry
clinicaltrials.gov
Start Date
January 14, 2019
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18-24 years
  • Not currently on ART
  • Provide written informed consent

Exclusion Criteria

  • Under 18 years or older than 24 years
  • Participants not willing to consent or unable to provide informed consent
  • Currently on ART

Outcomes

Primary Outcomes

The rate of linkage among women ages 18-24 years to HIV prevention services.

Time Frame: within 3 months of receiving the intervention

The rate of linkage per month of peer navigator activity to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive.

Secondary Outcomes

  • The number of linkages per 100 clinic referral slips distributed per arm;(within 3 months of receiving the intervention.)
  • The change in proportion of all residents (men and women) aged 18-24 years who are aware of HIV-SS and who have used HIV-SS over time(12 months following intervention end date)
  • Comparison of the difference per study area in the proportion of 18-24 year olds who report knowledge of HIV status and uptake of ART, PrEP and voluntary medical male circumcision (VMMC)(12 months following intervention end date)
  • Comparison of the pattern of recruitment per arm of study(12 months following intervention end date)
  • Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms(6 months study implementation period)

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