Home-based Intervention to Test and Start

NCT03757104 | Unknown

• 1 other identifier: A0001-BFC398/16
• Study Type: interventional
• Target: 4,667
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to establish the causal impact of two interventions - micro-incentives and a male-sensitive HIV- specific decision support app - on population-level HIV viral load and HIV-related mortality in men, as well as on population-based HIV incidence in young women.

Conditions

HIV; HIV Testing; Linkage to Care

Outcome Measures

Primary Outcomes (5)

• HIV testing uptake at point of test offer in men

  % received the rapid HIV test at home among those offered the test in men

  Baseline

• HIV treatment linkage at 1 year in men

  % who visited study clinics and initiated antiretroviral therapy (ART) in men

  year 1

• Population-level HIV viral suppression in men

  Change in proportion with detectable viremia in men; HIV testing and viral load measurements are performed on the dried blood spot (DBS) samples collected during the annual survey

  year 1

• Population-level HIV-related mortality in men

  Change in HIV-related mortality rate measured as the number of HIV-related deaths per 1000 person-years of observation in men

  year 3

• Population-level HIV incidence in young women (15-30 years of age)

  Change in HIV incidence rate (number of HIV sero-conversions per 100 person-years of follow up) in young women; HIV testing and viral load measurements are performed on the DBS samples collected during the annual survey

  year 3

Secondary Outcomes (26)

• HIV testing uptake at point of test offer in women

  Baseline

• HIV treatment linkage at 1 year in women

  year 1

• Population-level HIV viral suppression (both sexes)

  year 1

• Population-level HIV viral suppression (both sexes)

  year 3

• Population-level HIV viral suppression in women

  year 1

Study Arms (4)

micro-incentives

EXPERIMENTAL

micro-incentives only (8 communities)

Behavioral: micro-incentive

EPIC-HIV

EXPERIMENTAL

Empowered through informed choice for HIV \[male sensitive HIV specific decision support app\] (males only in 8 communities)

Behavioral: EPIC-HIV

micro-incentive and EPIC-HIV

EXPERIMENTAL

micro-incentives as well as EPIC \[male sensitive HIV specific decision support app\] (8 communities)

Behavioral: micro-incentive and EPIC-HIV

control

NO INTERVENTION

standard of care

Interventions

micro-incentive BEHAVIORAL

Residents in these communities are eligible to receive a R50 food voucher conditional on undergoing a home-based HIV test. If diagnosed with HIV, residents are eligible to receive a second R50 food voucher when they link to care within 6 weeks of the HIV test

Also known as: Food voucher

micro-incentives

EPIC-HIV BEHAVIORAL

Men in these communities are eligible to receive a tablet-based male-sensitive HIV decision support app (EPIC-HIV 1)to encourage them to test for HIV at home. If diagnosed with HIV and do not link to care within a month of HIV test, they become eligible to receive a tablet-based male HIV specific decision support app (EPIC-HIV 2) to encourage them to link to HIV care.

EPIC-HIV

micro-incentive and EPIC-HIV BEHAVIORAL

micro-incentives: Residents in these communities are eligible to receive a R50 food voucher conditional on undergoing a home-based HIV test. If diagnosed with HIV, residents are eligible to receive a second R50 food voucher when they link to care within 6 weeks of the HIV test. EPIC-HIV 1: Men in these communities are eligible to receive a tablet-based male-sensitive HIV specific decision support app (EPIC-HIV 1) to encourage them to test for HIV at home. If diagnosed with HIV and do not link to care within a month of HIV test, they become eligible to receive a tablet-based male HIV specific decision support app (EPIC-HIV 2) to encourage them to link to HIV care.

Also known as: Food Voucher and EPIC-HIV

micro-incentive and EPIC-HIV

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above
• Resident members of households within the Population Intervention Platform
• Have consented to participate in Population Intervention Platform
• additional eligibility criteria for EPIC-HIV
• Male

You may not qualify if:

• Refused to take part in Population Intervention Platform
• Participant reported to already be on ART

Sponsors & Collaborators

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

Study Sites (1)

AHRI

Mtubatuba, KwaZulu-Natal, 3935, South Africa

RECRUITING

Related Publications (5)

• Kim HY, Inghels M, Mathenjwa T, Shahmanesh M, Seeley J, Matthews P, Wyke S, McGrath N, Adeagbo O, Gareta D, Yapa HM, Zuma T, Dobra A, Blandford A, Barnighausen T, Tanser F. Effect of a Male-Targeted Digital Decision Support Application Aimed at Increasing Linkage to HIV Care Among Men: Findings from the HITS Cluster Randomized Clinical Trial in Rural South Africa. AIDS Behav. 2025 Jan;29(1):1-12. doi: 10.1007/s10461-024-04465-1. Epub 2024 Sep 11.

  PMID: 39259239 DERIVED

• Kim HY, Inghels M, Mathenjwa T, Shahmanesh M, Seeley J, Matthews P, McGrath N, Adeagbo O, Gareta D, Yapa HM, Zuma T, Dobra A, Barnighausen T, Tanser F. The impact of a conditional financial incentive on linkage to HIV care: Findings from the HITS cluster randomized clinical trial in rural South Africa. medRxiv [Preprint]. 2024 Mar 18:2024.03.15.24304278. doi: 10.1101/2024.03.15.24304278.

  PMID: 38562873 DERIVED

• Kim HY, Inghels M, Mathenjwa T, Shahmanesh M, Seeley J, Matthews P, Wyke S, McGrath N, Adeagbo O, Gareta D, Yapa HM, Zuma T, Dobra A, Blandford A, Barnighausen T, Tanser F. Effect of a male-targeted digital decision support application aimed at increasing linkage to HIV care among men: Findings from the HITS cluster randomized clinical trial in rural South Africa. medRxiv [Preprint]. 2024 Mar 18:2024.03.15.24304373. doi: 10.1101/2024.03.15.24304373.

  PMID: 38562824 DERIVED

• Makofane K, Kim HY, Tchetgen Tchetgen E, Bassett MT, Berkman L, Adeagbo O, McGrath N, Seeley J, Shahmanesh M, Yapa HM, Herbst K, Tanser F, Barnighausen T. Impact of family networks on uptake of health interventions: evidence from a community-randomized control trial aimed at increasing HIV testing in South Africa. J Int AIDS Soc. 2023 Aug;26(8):e26142. doi: 10.1002/jia2.26142.

  PMID: 37598389 DERIVED

• Tanser FC, Kim HY, Mathenjwa T, Shahmanesh M, Seeley J, Matthews P, Wyke S, McGrath N, Adeagbo O, Sartorius B, Yapa HM, Zuma T, Zeitlin A, Blandford A, Dobra A, Barnighausen T. Home-Based Intervention to Test and Start (HITS): a community-randomized controlled trial to increase HIV testing uptake among men in rural South Africa. J Int AIDS Soc. 2021 Feb;24(2):e25665. doi: 10.1002/jia2.25665.

  PMID: 33586911 DERIVED

Study Officials

• Frank Tanser, PhD

  Africa Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sashin Harilall

CONTACT

0312604113; sharilall@ahri.org

Thulile Mathenjwa

CONTACT

0355507500; tmathenjwa@ahri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 28, 2018
• Study Start: February 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

ZA (1)