ART AdherenceNCT03484533
HIV Self Testing of Male Partners of Women in PMTCT
A study testing HIV self-test kit in people with ART Adherence and PMTCT, run by University of Washington at 1 site in Uganda.
Trial summary
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who test and link to HIV care or prevention, compared to invitation letters for fast track… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ART Adherence, PMTCT, Linkage to Care
- What is being tested?
- HIV self-test kit
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 736 participants
- Where
- 1 siteUganda
- Study dates
- 17 May 2018to 22 Nov 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility
- For all participants
- Able and willing to provide written informed consent
- Able and willing to provide adequate locator information for study retention purposes
- For women
- Age ≥18
Show all 11Show fewer
- Currently pregnant
- HIV-positive based on positive rapid HIV tests, according to national algorithm
- Not currently enrolled in an HIV treatment study
- Male partner not known to be HIV-positive or has not tested in the past 3 months
- For men - In partnership with an HIV-positive pregnant woman in PMTCT B+
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Self-testing of Men to Increase Testing and Prevention Uptake Among Male Partners and Improve Postpartum ART Use in PMTCT B+ Programs in Uganda
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who test and link to HIV care or prevention, compared to invitation letters for fast track testing. Pregnant women who are randomized to the arm with secondary distribution of HIVST to their male partners will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. The investigators will offer men confirmatory testing regardless of their HIVST result, counseling, and if negative, pre-exposure prophylaxis (PrEP) and if positive, antiretroviral therapy (ART). The investigators will provide counseling to minimize social harms of HIV self-testing, and additional counseling and referral to social support services when social harms occur. This project will address key challenges in PMTCT B+ programs, by evaluating innovative strategies to increase male partner's knowledge of their HIV status, disclosure, and involvement coupled with offering PrEP to HIV-negative men, ART to HIV-positive men, and encouraging post-partum ART continuation and adherence among HIV-positive women.
Read the detailed description
Uganda has the fifth highest HIV burden globally and one of the highest fertility rates in Africa. Prevention of mother-to-child HIV transmission Option B+ (PMTCT B+) is national policy in Uganda. To maximize the prevention and clinical benefits of PMTCT B+, the challenges of low HIV testing by male partners and high rates of post-partum discontinuation of ART, insufficient adherence, and incomplete viral suppression need to be addressed. Women may be more likely to continue ART long-term and have higher adherence post-partum if their partner is tested, there is mutual disclosure of HIV status, and their partner takes ART or PrEP, depending on his status. Innovative approaches are needed to allow men to test in settings other than busy antenatal clinics, preferably where they have privacy, are comfortable and do not miss work. Innovative HIV testing technology -HIVST- could increase male partner's uptake of HIV testing, and prevention (PrEP) or ART (for all HIV-positive men). This study has been designed to address this gap through an enhanced PMTCT B+ program with HIV self-testing, and linkage to PrEP or ART, for male partners.
In a demonstration project the investigators recently completed among mutually disclosed East African HIV serodiscordant couples (the Partners Demonstration Project), integrated ART and PrEP delivery with time-limited PrEP for the HIV-negative partner as a 'bridge' until the HIV-positive partner was on ART for six months, and achieved viral suppression, was very acceptable, achieved very high uptake and adherence to ART and PrEP, and nearly eliminated HIV transmission. This protocol builds on that demonstration project by evaluating whether PMTCT outcomes are improved by increasing uptake of HIV testing and PrEP among HIV-negative men whose pregnant partner is HIV-positive. PrEP for HIV-negative male partners of HIV-positive pregnant women provides highly effective prevention benefits during an important 'season of risk' when men may have higher HIV acquisition risk from their partner if she is viremic (during the first few months after ART initiation, post-partum ART discontinuation or due to viral resistance), or from outside partners.
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women who are randomized to the HIVST arm, achieves higher uptake of their male partner's testing and linkages to HIV care and prevention among male partners, compared to invitation letters for fast track testing in the clinic (the standard of care). The investigators will recruit HIV-positive women ≥18 years accessing PMTCT B+ programs in Kampala, who have a male partner of unknown HIV status. Women will be randomized to the intervention (HIVST) or the control arm (invitation letters to deliver to partners to come for fast-track testing at the Antenatal Care (ANC) clinic where she receives care.
- Conditions
- ART Adherence, PMTCT, Linkage to Care, HIV, PrEP
- Being tested
- HIV self-test kit, Standard of Care (invitation letters for fast-track HIV testing in the clinic)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self-test kitBehavioural
Women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.
Standard of Care (invitation letters for fast-track HIV testing in the clinic)Behavioural
In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
| Study group | Role | What they receive |
|---|---|---|
| Women provided HIV Self-test kit | Active comparator | Women will be given HIV self-test kits that they can then deliver to their male partners. Receives: Behavioral: HIV self-test kit |
| Women provided invitation letter-standard of care | Active comparator | Women will be given an invitation letter for fast track HIV testing in the clinic that they will deliver to their male partners. Receives: Behavioral: Standard of Care (invitation letters for fast-track HIV testing in the clinic) |
| Male partners of women provided HIV self-test kit | Other | Male partners of women who were randomized to receive HIV self-test kits that could be delivered to their partner. Receives: Behavioral: HIV self-test kit |
| Male partners of women provided invitation letter | Other | Male partners of women who were randomized to receive an invitation letter - standard of care. Receives: Behavioral: Standard of Care (invitation letters for fast-track HIV testing in the clinic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV
Measured: Up to 12 months post-partum
The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of ART if they test HIV-positive.
Measured: Up to 12 months post-partum
The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of PrEP if they test HIV-negative
Measured: Up to 12 months post-partum
Secondary outcomes (2)
Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum viral suppression among HIV-infected Uganda women.
Measured: Up to 12 months post-partum
The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners
HIV-infected pregnant women and their male partners, experiences, perspectives and views on HIV self-testing evaluated by an inductive content analytic approach conducted through qualitative interviews. This does not permit quantification of numbers of persons who endorsed particular themes. The main themes reported were 1. Women's fear about delivering HIV self-testing kits to their partner particularly if they had not previously disclosed their HIV status to their partner. 2. Variable strategies used by women to introduce HIV self-testing to their male partners. 3. Range of male partner responses to receiving an HIV self-testing kit. 4. Women's confidence in ability to interpret HIV self-test results for their partners. 5. Women's strategies to persuade their partners to link to HIV care or HIV PrEP.
Measured: Up to 12 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start17 May 2018
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ART AdherenceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 736 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard University, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie Celum, MD MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484533
- Sponsor's protocol ID
- STUDY00002257
- Other IDs
- R01MH113434
- Status last verified
- Jun 2024
- First submitted
- 9 Mar 2018
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mujugira A, Nakyanzi A, Donnell D, Boyer J, Stein G, Bulterys M, Naddunga F, Kyomugisha J, Birungi JE, Ssendiwala P, Nsubuga R, Muwonge TR, Musinguzi J, Sharma M, Celum CL. Partner testing with HIV self-test distribution by Ugandan pregnant women living with HIV: a randomized trial. J Int AIDS Soc. 2023 Sep;26(9):e26156. doi: 10.1002/jia2.26156.
PubMed 37675834Bulterys MA, Mujugira A, Nakyanzi A, Wyatt MA, Kamusiime B, Kasiita V, Kakoola GN, Nalumansi A, Twesigye C, Pisarski EE, Sharma M, Boyer J, Naddunga F, Ware NC, Celum CL. "Him Leaving Me - That is My Fear Now": A Mixed Methods Analysis of Relationship Dissolution Between Ugandan Pregnant and Postpartum Women Living with HIV and Their Male Partners. AIDS Behav. 2023 Jun;27(6):1776-1792. doi: 10.1007/s10461-022-03910-3. Epub 2022 Nov 8.
PubMed 36348192Bulterys MA, Sharma M, Mugwanya K, Stein G, Mujugira A, Nakyanzi A, Twohey-Jacobs L, Ware NC, Heffron R, Celum C. Correlates of HIV Status Nondisclosure by Pregnant Women Living With HIV to Their Male Partners in Uganda: A Cross-Sectional Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):389-395. doi: 10.1097/QAI.0000000000002566.
PubMed 33148995