Home HIV Testing for Older Adults in South Africa (Test@Home)
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|ClinicalTrials.gov Identifier: NCT04131465|
Recruitment Status : Unknown
Verified February 2020 by Till Barnighausen, Harvard School of Public Health (HSPH).
Recruitment status was: Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : February 21, 2020
|First Submitted Date ICMJE||October 15, 2019|
|First Posted Date ICMJE||October 18, 2019|
|Last Update Posted Date||February 21, 2020|
|Actual Study Start Date ICMJE||May 15, 2019|
|Estimated Primary Completion Date||May 15, 2020 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Home HIV Testing for Older Adults in South Africa|
|Official Title ICMJE||Home HIV Testing for Older Adults and Their Family and Community Members: a Three-arm Randomized Controlled Trial in Rural South Africa|
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
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.
This study thus aims to:
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 ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||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)
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
|Study Arms ICMJE||
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Actual Enrollment ICMJE
|Original Actual Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||December 2021|
|Estimated Primary Completion Date||May 15, 2020 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||40 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||South Africa|
|Removed Location Countries|
|NCT Number ICMJE||NCT04131465|
|Other Study ID Numbers ICMJE||NIH/NIA- 2P01AG041710-04|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Current Responsible Party||Till Barnighausen, Harvard School of Public Health (HSPH)|
|Original Responsible Party||Same as current|
|Current Study Sponsor ICMJE||Harvard School of Public Health (HSPH)|
|Original Study Sponsor ICMJE||Same as current|
|PRS Account||Harvard School of Public Health (HSPH)|
|Verification Date||February 2020|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP