Clinical trial NCT03751826: Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention
Official title: Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa: A Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Africa Health Research Institute
name: London School of Hygiene and Tropical Medicine
First posted: 2018-11-23
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The unit of randomisation will be pairs of peer navigators: 21 pairs of peer navigators will be randomised to 3 arms: two intervention arms, and standard of care (7 pairs per arm).
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Females
* 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
* Males
* Currently on ART

Primary outcomes:
measure: The rate of linkage among women ages 18-24 years to HIV prevention services.
timeFrame: within 3 months of receiving the intervention
Secondary outcomes:
measure: The number of linkages per 100 clinic referral slips distributed per arm;
timeFrame: within 3 months of receiving the intervention.
measure: 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
timeFrame: 12 months following intervention end date
measure: 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)
timeFrame: 12 months following intervention end date
measure: Comparison of the pattern of recruitment per arm of study
timeFrame: 12 months following intervention end date
measure: Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms
timeFrame: 6 months study implementation period
Other outcomes:
Locations:
Study officials:
affiliation: University College London and Africa Health Research Institute
name: Maryam Shahmanesh, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahmanesh M, Mthiyane TN, Herbsst C, Neuman M, Adeagbo O, Mee P, Chimbindi N, Smit T, Okesola N, Harling G, McGrath N, Sherr L, Seeley J, Subedar H, Johnson C, Hatzold K, Terris-Prestholt F, Cowan FM, Corbett EL. Effect of peer-distributed HIV self-test kits on demand for biomedical HIV prevention in rural KwaZulu-Natal, South Africa: a three-armed cluster-randomised trial comparing social networks versus direct delivery. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004574. doi: 10.1136/bmjgh-2020-004574.
citation: Adeagbo OA, Mthiyane N, Herbst C, Mee P, Neuman M, Dreyer J, Chimbindi N, Smit T, Okesola N, Johnson C, Hatzold K, Seeley J, Cowan F, Corbett L, Shahmanesh M. Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol. BMJ Open. 2019 Dec 23;9(12):e033435. doi: 10.1136/bmjopen-2019-033435.