Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention
- Conditions
- HIV
- Registration Number
- NCT03751826
- Lead Sponsor
- University College, London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2000
- Females
- Aged 18-24 years
- Not currently on ART
- Provide written informed consent
- Under 18 years or older than 24 years
- Participants not willing to consent or unable to provide informed consent
- Males
- Currently on ART
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The rate of linkage among women ages 18-24 years to HIV prevention services. 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 Outcome Measures
Name Time Method The number of linkages per 100 clinic referral slips distributed per arm; within 3 months of receiving the intervention. The number of linkages to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive per 100 clinic referral slips distributed per arm.
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 Using routine annually collected data from the surveillance area
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 Using routine annually collected data from the surveillance area
Comparison of the pattern of recruitment per arm of study 12 months following intervention end date The proportion of hard to reach adolescent girls and young women (aged 18-24 years) - defined as out of school, recently migrated and those who live in remote areas - linked to care in the three arms of study
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 To establish costs, we will use both a bottom-up ingredient-based costing approach and a top-down costing approach using the study budgets and expenditure reports.