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

HIV Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03751826
• Other study ID #: 15990
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: University College, London
• Contact: Carina Herbst
• Phone: +27 (0)35 550 7500
• Email: Carina.Herbst[@]ahri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Incentivised network delivery of HIV-ST
Peer 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.
• Peer navigator delivery of HIV-ST
Peer 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.
• standard of care
Peer 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Africa Health Research Institute, London School of Hygiene and Tropical Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of linkage among women ages 18-24 years to HIV prevention services.	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.	within 3 months of receiving the intervention
Secondary	The number of linkages per 100 clinic referral slips distributed per arm;	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.	within 3 months of receiving the intervention.
Secondary	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	Using routine annually collected data from the surveillance area	12 months following intervention end date
Secondary	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)	Using routine annually collected data from the surveillance area	12 months following intervention end date
Secondary	Comparison of the pattern of recruitment per arm of study	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	12 months following intervention end date
Secondary	Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms	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.	6 months study implementation period