Home HIV Testing for Older Adults in South Africa (Test@Home)

• ClinicalTrials.gov Identifier: NCT04131465
• Recruitment Status: Unknown
• First Posted: October 18, 2019
• Last Update Posted: February 21, 2020
• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: University of Heidelberg Medical Center; University of Witwatersrand, South Africa
• Information provided by (Responsible Party): Till Barnighausen, Harvard School of Public Health (HSPH)

Tracking Information

• First Submitted Date: October 15, 2019
• First Posted Date: October 18, 2019
• Last Update Posted Date: February 21, 2020
• Actual Study Start Date: May 15, 2019
• Estimated Primary Completion Date: May 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2020)

• Ever tested for HIV [ Time Frame: 9 months ]
  Binary endpoint: participant has ever tested for HIV vs. has never tested for HIV
• Recent HIV testing [ Time Frame: 9 months ]
  Binary endpoint: participant has tested since enrollment in the HIV trial vs. participant has not tested since enrollment in the HIV trial

Original Primary Outcome Measures (submitted: October 15, 2019)

• Ever tested for HIV [ Time Frame: 9 months ]
  Binary endpoint: participant has ever tested for HIV vs. has never tested for HIV
• Recent HIV testing [ Time Frame: 9 months ]
  Binary endpoint: participant has tested within the past 6 months vs. participant has not tested within the past 6 months

Current Secondary Outcome Measures (submitted: February 19, 2020)

• Use of HIV self-test [ Time Frame: 9 months ]
  Binary outcome: participant has used HIV self-test since enrollment in the HIV trial vs. participant has not used an HIV self-test since enrollment in the HIV trial
• Repeated HIV testing [ Time Frame: 9 months ]
  Binary outcome: having tested at least twice since enrollment in the HIV trial vs. having tested once or fewer times since enrollment in the HIV trial
• HIV status knowledge [ Time Frame: 9 months ]
  Binary outcome: participant reports that he/she knows his/her HIV status
• Correct report of HIV status [ Time Frame: 9 months ]
  Binary outcome: participant correctly reports HIV status evaluated against biomarker HIV status vs. participant does not know or correctly report HIV status
• Use of home rapid HIV test [ Time Frame: 9 months ]
  Binary outcome: participant has used a rapid HIV test at home since enrollment in the HIV trial vs. particpant has not used rapid HIV test since enrollment in the HIV trial
• HIV testing at healthcare facility [ Time Frame: 9 months ]
  Binary outcome: participant has tested for HIV at a facility since enrollment in the HIV trial vs. participant has not tested for HIV at a facility since enrollment in the HIV trial
• Linkage to HIV treatment and care [ Time Frame: 9 months ]
  Binary outcome: participant has ever visited a facility where HIV treatment and care is available vs. participant has never visited a facility where HIV treatment and care is available
• Recent linkage to HIV treatment and care [ Time Frame: 9 months ]
  Binary outcome: participant has visited a facility where HIV treatment and care is available since enrollment in the HIV trial vs. participant has not visited a facility where HIV treatment and care is available since enrollment in the HIV trial
• Number of recent sex partners [ Time Frame: 9 months ]
  Count variable: number of sex partners since enrollment in the HIV trial
• Recent condom use [ Time Frame: 9 months ]
  Binary variable: participant has used condom with most recent sex partner vs. participant has not used condom with most recent sex partner
• Most recent sex partner was casual or anonymous [ Time Frame: 9 months ]
  Binary variable: most recent sex partner was casual or anonymous vs. most recent sex partner was neither casual nor anonymous
• Rapid HIV testing during HAALSI [ Time Frame: 9 months ]
  Binary outcome: participant used a rapid HIV test as part of the field operations of the mother study (HAALSI) since enrollment in the HIV trial vs. participant did not use an HIV test as part of the mother study since enrollment in the HIV trial
• HIV treatment uptake [ Time Frame: 9 months ]
  Binary outcome: participant has started HIV treatment vs. participant has not started HIV treatment
• Antihypertensive treatment [ Time Frame: 9 months ]
  Binary outcome: participant is currently receiving antihypertensive treatment vs. participant is currently not receiving antihypertensive treatment
• Diabetes treatment [ Time Frame: 9 months ]
  Binary outcome: participant currently receives diabetes treatment vs. participant currently does not receive diabetes treatment
• Satisfaction with the fieldworker visit [ Time Frame: 9 months ]
  Scale
• Satisfaction with the South African government and healthcare system [ Time Frame: 9 months ]
  Scale
• Trust in other people and healthcare providers [ Time Frame: 9 months ]
  Scale
• Depressive Symptoms [ Time Frame: 9 months ]
  CESD Scale
• Viral load [ Time Frame: 18-24 months ]
  Continuous variable: viral load
• Blood pressure [ Time Frame: 18-24 months ]
  Continuous outcome: blood pressure, systolic and diastolic
• Blood sugar [ Time Frame: 18-24 months ]
  Continous outcome: glucose or hemoglobin A1c
• Biological Antiretroviral Screening [ Time Frame: 18-24 months ]
  Binary Outcome: Presence of ART in blood

Original Secondary Outcome Measures (submitted: October 15, 2019)

• Use of HIV self-test [ Time Frame: 9 months ]
  Binary outcome: participant has used HIV self-test in the past 6 months vs. participant has not used an HIV self-test in the past 6 months
• Repeated HIV testing [ Time Frame: 9 months ]
  Binary outcome: having tested at least twice in the past 6 months vs. having tested once or fewer times in the past 6 months
• HIV status knowledge [ Time Frame: 9 months ]
  Binary outcome: participant reports that he/she knows his/her HIV status
• Correct report of HIV status [ Time Frame: 9 months ]
  Binary outcome: participant correctly reports HIV status evaluated against biomarker HIV status vs. participant does not know or correctly report HIV status
• Use of home rapid HIV test [ Time Frame: 9 months ]
  Binary outcome: participant has used a rapid HIV test at home in the past 6 months vs. particpant has not used rapid HIV test in the past 6 months
• HIV testing at healthcare facility [ Time Frame: 9 months ]
  Binary outcome: participant has tested for HIV at a facility in the past 6 months vs. participant has not tested for HIV at a facility in the past 6 months
• Linkage to HIV treatment and care [ Time Frame: 9 months ]
  Binary outcome: participant has ever visited a facility where HIV treatment and care is available vs. participant has never visited a facility where HIV treatment and care is available
• Recent linkage to HIV treatment and care [ Time Frame: 9 months ]
  Binary outcome: participant has visited a facility where HIV treatment and care is available in the past 6 months vs. participant has not visited a facility where HIV treatment and care is available in the past 6 months
• Number of recent sex partners [ Time Frame: 9 months ]
  Count variable: number of sex partners in the past 6 months
• Recent condom use [ Time Frame: 9 months ]
  Binary variable: participant has used condom with most recent sex partner vs. participant has not used condom with most recent sex partner
• Most recent sex partner was casual or anonymous [ Time Frame: 9 months ]
  Binary variable: most recent sex partner was casual or anonymous vs. most recent sex partner was neither casual nor anonymous
• Rapid HIV testing during HAALSI [ Time Frame: 9 months ]
  Binary outcome: participant used a rapid HIV test as part of the field operations of the mother study (HAALSI) in the past 6 months vs. participant did not use an HIV test as part of the mother study in the past 6 months
• HIV treatment uptake [ Time Frame: 9 months ]
  Binary outcome: participant has started HIV treatment vs. participant has not started HIV treatment
• Antihypertensive treatment [ Time Frame: 18-24 months ]
  Binary outcome: participant is currently receiving antihypertensive treatment vs. participant is currently not receiving antihypertensive treatment
• Diabetes treatment [ Time Frame: 18-24 months ]
  Binary outcome: participant currently receives diabetes treatment vs. participant currently does not receive diabetes treatment
• Viral load [ Time Frame: 18-24 months ]
  Continuous variable: viral load
• Blood pressure [ Time Frame: 18-24 months ]
  Continuous outcome: blood pressure
• Blood sugar [ Time Frame: 18-24 months ]
  Continous outcome: glucose or hemoglobin A1c
• Biological Antiretroviral Screening [ Time Frame: 18-24 months ]
  Binary Outcome: Presence of ART in blood

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Home HIV Testing for Older Adults in South Africa
• Official Title: Home HIV Testing for Older Adults and Their Family and Community Members: a Three-arm Randomized Controlled Trial in Rural South Africa

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. Establish the comparative effectiveness of three home-based HIV testing options among older adults in rural South Africa
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. Determine the comparative cost-effectiveness of the three home-based HIV testing options among older adults.

Detailed Description

Background In the first wave of a large population-representative study of older adults in rural South Africa, the 'Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI)' study, large gaps in knowledge of HIV status were found among participants, coupled with low rates of recent HIV testing and high rates of sexual behaviour that can lead to acquisition and transmission of HIV. In general, older adults should test for HIV at least once per year (HIVAge.org), but few do so, in part because current HIV testing programmes have traditionally focused on young and middle-age adults and HIV testing facilities are often difficult to access for older populations. Only 17% of older adults in the HAALSI community reported having tested for HIV in the past 6 months.

Home testing can provide a powerful approach to bring the health systems 'function' of HIV testing to older adults in rural Africa. In the routine health system, community health workers, such as the South African community care givers, could provide this 'function' on a regular basis. Home rapid HIV testing and HIV self-test kits have been intensively studied in many populations. HIV self-test kits have recently become available as over the- counter products in South Africa, after the South African Pharmacy Council (SAPC) lifted a ban on their sale in pharmacies in December 2016.

To date, however, no study has compared head-to-head different 'forms' of home testing for HIV. In this study, the investigators aim to establish the comparative effectiveness and cost-effectiveness of three different options of home HIV testing among older adults in rural South Africa: (1) home delivery of HIV self-test kits, (2) home HIV rapid testing, and (3) both home delivery of HIV self-test kits and home HIV rapid testing.

Overall, home HIV testing is likely attractive for older adults because it allows testing without having to visit a health care facility. Home delivery of HIV self-testing kits has the additional advantage that it allows HIV testing in a place and at a time of one's own choosing. Home approaches to HIV testing are particularly policy-relevant at this time, because South Africa and many other countries in sub-Saharan Africa are currently expanding in re-designing their community health worker programs, through which home HIV testing could be provided on a routine basis.

Preliminary evidence in this and in other populations have suggested that HIV testing and linkage to HIV treatment and care improve health care utilization for other non-HIV chronic care and reduce risky sexual behavior. The investigators will thus not only assess the effects of the different home HIV testing offers on HIV testing but also assess comparative effects on healthcare utilization, noncommunicable disease endpoints, and sexual behaviors.

Research Aims

This study thus aims to:

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

Study Design Participants in Wave 2 of the HAALSI study will be offered one of three options (randomly assigned 1:1:1) for home HIV testing: (1) three oral HIV self-test kits with a brief introduction to HIV self-testing (home HIV self-testing arm), (2) home rapid HIV testing and counselling (home rapid HIV testing arm), and (3) three oral HIV self-test kits with a brief introduction to HIV self-testing plus home rapid HIV testing and counselling (home HIV self-testing and HIV rapid testing arm). The brief introduction to HIV self-testing will include encouragement of both self-use and onward distribution to household and community members.

The HAALSI participants were randomized (sample ~3,600; 1,200 individuals in each of the three arms). Randomization has occurred during routine HAALSI fieldwork visits, using a pre-programmed randomization process that is integrated into the tablet-based HAALSI computer-assisted personal interview (CAPI). This randomization was completed during a three-month period between May and July 2019.

Outcome Assessment The primary outcomes (1-2) and a group of secondary outcomes (3-21) will be assessed by telephone at 9 months after randomization. Based on the timing of randomization, primary data collection will take place from February through May 2020. Then, both the primary and an expanded set of secondary outcomes including several biologically-measured secondary outcomes (1-25) will be assessed at 18-24 months, during the subsequent, planned cohort-based data collection (HAALSI Wave 3).

Power Calculation In the first wave of the HAALSI study, the proportion of people having tested for HIV in the past 6 months (which was about 17%) was measured. Assuming uniform distribution of testing over time, it would be expected that about 3% of older adults in the HAALSI population tested in the past month. Based on the HAALSI 1 data, the proportion of older adults who ever tested for HIV is 65%. Given these estimates for the endpoints in the control arm, this study is powered to detect a 3 percentage point difference in HIV testing in the past month and a 6 percentage point difference in ever testing for HIV across the three arms. For this power calculation the investigators further assumed, 20% loss to follow-up, 80% power and a significance level for rejecting the Null hypothesis of 0.0167. This significance level results from the adjustment of the standard 0.05 significance level for multiple hypothesis testing - each arm compared to each other arm - using the Holm-Bonferroni method.

Data Analyses The investigators will measure risk ratios for all the binary outcomes in this study, using modified Poisson regression implemented in generalized linear models with Poisson distribution and log link. Furthermore, the effect sizes for count outcomes using generalized linear models with negative binomial distribution and log link will be measured; the investigators will measure effect sizes for continuous outcomes using generalized linear models with normal distribution and identity link. All estimations will be adjusted for clustering of outcomes at the household level as well as for baseline values of the endpoints. Baseline values of our primary and secondary endpoints will be assessed during the baseline visit before the HAALSI participants receive the trial exposure.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Health Services Research

Condition

• HIV Infections
• Knowledge, Attitudes, Practice

Intervention

• Diagnostic Test: Home HIV self-testing
  Offer of 3 OraQuick HIV self-test kits
• Diagnostic Test: Home HIV rapid testing
  Offer of HIV rapid testing with Alere Determine HIV-1/2
• Diagnostic Test: Home HIV self-testing and rapid testing
  Offer of 3 OraQuick HIV self-test kits and HIV rapid testing with Alere Determine HIV-1/2

Study Arms

• Experimental: Home HIV self-testing
  Fieldworkers will visit potential participants in their homes and offer 3 oral HIV self-testing kits with a short introduction to HIV self-testing.
  Intervention: Diagnostic Test: Home HIV self-testing
• Experimental: Home HIV rapid testing
  Fieldworkers will visit potential participants in their homes and offer home-based HIV rapid testing and counselling.
  Intervention: Diagnostic Test: Home HIV rapid testing
• Experimental: Home HIV self-testing and rapid testing
  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.
  Intervention: Diagnostic Test: Home HIV self-testing and rapid testing

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 15, 2019): 3578
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: May 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants who meet the inclusion criteria but do not wish to participate in this study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT04131465
• Other Study ID Numbers: NIH/NIA- 2P01AG041710-04
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified individual data for all primary and secondary outcome measures will be made available. Investigators from institutions outside those listed in this registration will be requested to obtain ethics permissions or exemptions for any analyses using these data from their institutional review boards.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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.

• Current Responsible Party: Till Barnighausen, Harvard School of Public Health (HSPH)
• Original Responsible Party: Same as current
• Current Study Sponsor: Harvard School of Public Health (HSPH)
• Original Study Sponsor: Same as current

Collaborators

• University of Heidelberg Medical Center
• University of Witwatersrand, South Africa

Investigators

• Principal Investigator: Till Bärnighausen, MD; Harvard School of Public Health (HSPH)

• PRS Account: Harvard School of Public Health (HSPH)
• Verification Date: February 2020