Home HIV Testing for Older Adults in South Africa

NCT04131465 | Unknown DMC

• 1 other identifier: NIH/NIA- 2P01AG041710-04
• Study Type: interventional
• Target: 3,578
• Locations: 1 country
• Sites: 1

Brief Summary

Many older adults in rural South Africa still lack knowledge of their HIV status despite a high probability of infection. Older adults tend to test less for HIV because most HIV testing and prevention programs have been targeted at younger age groups. Other reasons for failure to test for HIV include frailty and lack of financial resources to travel to HIV testing centers. Home-based testing is a powerful approach to bring HIV testing services -- and HIV status knowledge -- to older adults. In real-life health systems, community health workers, such as the South African community care givers, could potentially provide home-based HIV testing on a routine basis. In this study, the investigators are trying to establish the best 'form' for the 'function' home-based HIV testing. Specifically, the investigators aim to

1. 1.Establish the comparative effectiveness of three home-based HIV testing options among older adults in rural South Africa
2. 2.Identify spill-over effects of the different home-based HIV testing options to other adults in the households and communities of the older adults receiving the testing options
3. 3.Determine the comparative cost-effectiveness of the three home-based HIV testing options among older adults.

Conditions

HIV Infections; Knowledge, Attitudes, Practice

Keywords

HIV testing; HIV status knowledge; Health system; Community health workers

Outcome Measures

Primary Outcomes (2)

• Ever tested for HIV

  Binary endpoint: participant has ever tested for HIV vs. has never tested for HIV

  9 months

• Recent HIV testing

  Binary endpoint: participant has tested since enrollment in the HIV trial vs. participant has not tested since enrollment in the HIV trial

  9 months

Secondary Outcomes (23)

• Use of HIV self-test

  9 months

• Repeated HIV testing

  9 months

• HIV status knowledge

  9 months

• Correct report of HIV status

  9 months

• Use of home rapid HIV test

  9 months

Study Arms (3)

Home HIV self-testing

EXPERIMENTAL

Fieldworkers will visit potential participants in their homes and offer 3 oral HIV self-testing kits with a short introduction to HIV self-testing.

Diagnostic Test: Home HIV self-testing

Home HIV rapid testing

EXPERIMENTAL

Fieldworkers will visit potential participants in their homes and offer home-based HIV rapid testing and counselling.

Diagnostic Test: Home HIV rapid testing

Home HIV self-testing and rapid testing

EXPERIMENTAL

Fieldworkers will visit participants in their homes and offer 3 oral HIV self-testing kits with a short introduction to HIV self-testing as well as home-based HIV rapid testing and counselling.

Diagnostic Test: Home HIV self-testing and rapid testing

Interventions

Home HIV self-testing DIAGNOSTIC_TEST

Offer of 3 OraQuick HIV self-test kits

Home HIV self-testing

Home HIV rapid testing DIAGNOSTIC_TEST

Offer of HIV rapid testing with Alere Determine HIV-1/2

Home HIV rapid testing

Home HIV self-testing and rapid testing DIAGNOSTIC_TEST

Offer of 3 OraQuick HIV self-test kits and HIV rapid testing with Alere Determine HIV-1/2

Home HIV self-testing and rapid testing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants need to be part of the second wave of a population-representative longitudinal study in rural South Africa: "Health and Aging in Africa: A Longitudinal Study of an INDEPTH community in South Africa" (HAALSI)
• Mental capacity to consent to participation in this study

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• University of Heidelberg Medical Center: collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

MRC/Wits Rural, Public Health and Health Transitions Research Unit (Agincourt)

Acornhoek, Mpumalanga, 1360, South Africa

Location

Related Publications (1)

• Gomez-Olive FX, Montana L, Wagner RG, Kabudula CW, Rohr JK, Kahn K, Barnighausen T, Collinson M, Canning D, Gaziano T, Salomon JA, Payne CF, Wade A, Tollman SM, Berkman L. Cohort Profile: Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI). Int J Epidemiol. 2018 Jun 1;47(3):689-690j. doi: 10.1093/ije/dyx247. No abstract available.

  PMID: 29325152 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Behavior

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Till Bärnighausen, MD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will not know the arm assignment when they assess the outcomes. The investigators analyzing the data for the initial effect size estimations will be blinded to the arm assignment. Care providers (i.e., the fieldworkers providing the home-based HIV testing) and participants cannot be blinded to the assignment to the trial arms.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Global Health

Model Details: This study will randomize older adults living in a rural community in South Africa to one of three trial arms.

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: May 15, 2019
• Primary Completion: May 15, 2020
• Study Completion: December 1, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by the publication committee of the mother study (HAALSI). Requestors will be required to sign a Data Access Agreement.

Locations

ZA (1)