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

NCT03751826 | Unknown DMC

• 1 other identifier: 15990
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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. 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Incentivised network delivery HIV-ST

EXPERIMENTAL

Peer-navigators will use respondent-driven sampling to distribute HIV-ST kits through 'seeds'. Each 'seed' (female aged 18-24 years) will receive a session on HIV prevention, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. Seeds will be asked to recruit females aged 18-24 years and given 5 uniquely numbered incentivized recruitment coupons with HIV-ST kits to pass on to their peers. Individual who return the coupons will undergo the same procedure as the seeds above and the individual who handed out the coupon will receive a sum of $1.5 in airtime per friend who returns the coupon. The packs include referral slips with information on how to link to HIV community-based confirmatory testing, HIV treatment and PrEP.

Other: Incentivised network delivery of HIV-ST

Peer Navigator distributed HIV-ST

EXPERIMENTAL

Peer navigators will directly distribute HIV-ST kits to females aged 18-24 years over a period of six months. Each person recruited will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV-ST. The packs include referral slips with information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP.

Other: Peer navigator delivery of HIV-ST

Standard of care

ACTIVE COMPARATOR

Peer navigators will encourage females aged 18-24 years to test for HIV at clinics, and link to services/care. Each female aged 18-24 approached by a peer navigator will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. They will then be given a referral slip for HIV testing through the clinic. The referral slips include information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP.

Other: standard of care

Interventions

Incentivised network delivery of HIV-ST OTHER

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.

Incentivised network delivery HIV-ST

Peer navigator delivery of HIV-ST OTHER

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.

Peer Navigator distributed HIV-ST

standard of care OTHER

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.

Standard of care

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: everyone is eligible to receive the HIV self screen, but the primary outcome of linkage to care is only measured in self identified females aged aged 18-24 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Africa Health Research Institute: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Related Publications (2)

• 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.

  PMID: 34315730 DERIVED

• 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.

  PMID: 31874891 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maryam Shahmanesh, MRCP PhD

  University College London and Africa Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Herbst

CONTACT

+27 (0)35 550 7500; Carina.Herbst@ahri.org

Ncengani Mthethwa

CONTACT

+27 (0)800 203 695; NMthethwa@ahri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 23, 2018
• Study Start: January 14, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The study team will have exclusive use of the data for 2 years after the study and/or once the primary analysis of the study has been published, whichever comes first. Data may be made available sooner at the discretion of the investigators, where this does not conflict with the publication plans for the study. After the period of exclusive use, data will be made available to potential new users on request.
• Access Criteria: The data custodian has the administrative control over granting access to the data to researchers. Anonymized electronic quantitative datasets will be archived and made available to interested external researchers. Requests for data sharing are reviewed by the data custodian and a Data Sharing committee at AHRI. All AHRI staff are bound by the AHRI Data Access Policy, which prohibits any sharing of data with third parties, unless a formal Data Use Agreement has been signed with the third party. The Data Use Agreement defines the analyses to be undertaken. If approved the study would have to undergo relevant IRB and ethical review processes.