Clinical Trials Directory

Trials / Unknown

UnknownNCT03751826

Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
2,000 (estimated)
Sponsor
University College, London · Academic / Other
Sex
Female
Age
18 Years – 24 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERIncentivised network delivery of HIV-STPeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the first intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV themselves and in their peers and friends. They will be counselled to receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
OTHERPeer navigator delivery of HIV-STPeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the second intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV and then receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
OTHERstandard of carePeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the standard of care arm encourage females aged 18-24 to test for HIV, receive sexual and reproductive health services, contraception and condoms, and link to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.

Timeline

Start date
2019-01-14
Primary completion
2019-10-31
Completion
2019-12-31
First posted
2018-11-23
Last updated
2018-11-23

Source: ClinicalTrials.gov record NCT03751826. Inclusion in this directory is not an endorsement.