Human Immunodeficiency VirusJamii BoraNCT03547739
Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
A study testing Home visits and HIV Self-testing in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 1 site in Kenya.
Trial summary
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Home visits and HIV Self-testing
- 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
- 1,600 participants
- Where
- 1 siteKenya
- Study dates
- 20 Mar 2019to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at 36 weeks of pregnancy or less
- 15 years of age or older
- Has been offered HIV testing at ANC
- Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
- Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
- Not in an HIV-positive concordant relationship.
Who cannot join
- Greater than 36 weeks of pregnancy
- Less than 15 years of age
- Not currently in a stable relationship with a male partner
- Does not currently live with male partner
- Has not been offered HIV testing at ANC
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.
Read the detailed description
Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Home visits, HIV Self-testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitsBehavioural
If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.
HIV Self-testingBehavioural
Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.
| Study group | Role | What they receive |
|---|---|---|
| Home visits | Active comparator | Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker. Receives: Behavioral: Home visits |
| HIV Self-testing | Active comparator | Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points. Receives: Behavioral: HIV Self-testing |
| Standard Care | No intervention | Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum
Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.
Measured: up to 12 months postpartum
Secondary outcomes (18)
HIV Re-testing
Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire.
Measured: Up to 12 months postpartum
Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)
Number of new HIV-positive test results of male partners from baseline to 12 months postpartum and coded as Y=those who had tested for HIV individually up to 12 months postpartum and N=those who had not tested for HIV individually up to 12 months postpartum.
Measured: Up to 12 months postpartum
Number of New Discordant Couples (Intervention Arms Only)
Number of new HIV serodiscordant couples identified during observation period.
Measured: Up to 12 months postpartum
HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum
Composite variable based on self-report data from women's questionnaires, coded as Y=those who were coded as Y on the three variables described below and N= those who were coded as N on one, two, or three variables described below: (1) mothers use of antiretrovirals (ARVs) (Y=those mothers who have used ARVs from baseline up to 18 months postpartum/N=those mothers who have not used ARVs at any time point between baseline up to 18 months postpartum), (2) prophylactic ARVs given to the infant (Y=those infants who were given prophylactic ARVs up to 18 months after the birth/N=those infants who were not given prophylactic ARVs at any point from birth up to 18 months after the birth), and (3) Y=if exclusive breastfeeding was practiced up to 6 months after the birth and N=if exclusive breastfeeding was not practiced up to 6 months after the birth.
Measured: Up to 18 months postpartum
Women Who Utilized All 4 MCH Services up to 3 Months Postpartum
Composite variable based on self-report data from women's questionnaires: Y=if all described variables coded as Y, N=if at least one of the following variables coded as N: (1) Y=if a woman completed at least four antenatal care (ANC) visits during this pregnancy, N=if a woman completed less than four ANC visits during this pregnancy; (2) Y=if a childbirth was with a skilled attendant, N=if a childbirth was not with a skilled attendant; (3) Y=if a postpartum check-up was completed for a woman and N=if the women did not have a postpartum check-up, and (4) Y=if the infant had a postnatal check-up, N=if a if a postnatal check-up was not completed for the infant. These are assessed in the follow-up questionnaires completed up to 3 months postpartum.
Measured: Up to 3 months postpartum
Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline)
Initiation of PrEP by participants with HIV-negative status at baseline, assessed at each follow-up in the questionnaires up to 18 months after the baby's birth.
Measured: Up to 18 months postpartum
Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
Number of HIV-positive women not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive woman at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.
Measured: Up to 12 months postpartum
Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up
Woman's retention in HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive woman at baseline has not been retained in HIV up to 12 months postpartum.
Measured: Up to 12 months postpartum
Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up)
Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job she was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each woman at each time point.
Measured: Up to 12 months postpartum
Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up)
Mean number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records.
Measured: Up to 12 months postpartum
Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
Number of HIV-positive men not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive man at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.
Measured: Up to 12 months postpartum
Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up
Men's retention in HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive man at baseline has not been retained in HIV up to 12 months postpartum.
Measured: Up to 12 months postpartum
Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum)
Mean self-reported adherence to ART assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job he was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each male partner at each time point using these three items.
Measured: Up to 12 months postpartum
Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum)
Mean number of HIV care visits assessed for HIV-positive men from baseline up to 12 months postpartum.
Measured: Up to 12 months postpartum
Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)
Viral Load < 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.
Measured: Up to 18 months postpartum
HIV-free Child Survival
Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.
Measured: 18 months after the birth
Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum
Number of infants of HIV-positive mothers who tested HIV+ up to 18 months postpartum based on medical records. This is be a Y/N variable with Y if the infant tested HIV+ up to 18 months postpartum and N if they did not test HIV+.
Measured: Up to 18 months after birth
Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up)
Time to first infant HIV test based on medical records. This is the number of weeks since the baby's birth to the first HIV test and is reported as a median weeks value for each study arm.
Measured: Up to 18 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start20 Mar 2019
- Primary completion27 Jun 2024
- Study completion23 Oct 2024
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 (4)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of Michigan, University of Witwatersrand, South Africa, University of Pennsylvania, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Janet M. Turan, PhD, University of Alabama at Birmingham
- Investigators
- Janet M Turan, PhD, MPH, Principal investigator, University of Alabama at BirminghamLynae Darbes, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547739
- Sponsor's protocol ID
- IRB-300001427
- Other IDs
- 000518108, R01MH116736
- Acronym
- Jamii Bora
- Status last verified
- Jul 2025
- First submitted
- 9 May 2018
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwena Z, Kimbo L, Darbes LA, Hatcher AM, Helova A, Owino G, Thirumurthy H, Bukusi EA, Braun T, Kilgore M, Pisu M, Tamhane A, Nghiem VT, Agot K, Neilands TB, Turan JM. Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):19. doi: 10.1186/s13063-020-04956-1.
PubMed 33407784Borgstede SJ, Elly A, Helova A, Kwena Z, Darbes LA, Hatcher A, Thirumurthy H, Owino G, Pisu M, Owuor K, Braun T, Turan JM, Bukusi EA, Nghiem VT. Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya. Value Health Reg Issues. 2023 Mar;34:125-132. doi: 10.1016/j.vhri.2022.11.003. Epub 2023 Jan 27.
PubMed 36709657Turan JM, Kwena ZA, Owuor K, Helova A, Hatcher AM, Braun TM, Owengah E, Okombo M, Nghiem VT, Thirumurthy H, Bukusi EA, Darbes LA. Effectiveness of interventions to promote couples-based HIV testing and family health during pregnancy and postpartum in Kenya: a multicentre, couples-based, randomised controlled trial. Lancet HIV. 2026 Sep;13(9):e631-e642. doi: 10.1016/S2352-3018(26)00104-9. Epub 2026 Jun 29.
PubMed 42372779Buyukcan-Tetik A, Ergun TD, Turan B, Mukerji R, Owuor K, Hatcher A, Bukusi EA, Kwena Z, Helova A, Owengah E, Darbes L, Turan JM. HIV-related stigma, couple relationship quality, and mental health in sero-discordant pregnant couples in Kenya. Appl Psychol Health Well Being. 2026 Feb;18(1):e70120. doi: 10.1111/aphw.70120.
PubMed 41607089
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
- ClinicalTrials.gov ID
- NCT03547739
- Acronym / sponsor ID
- Jamii Bora / IRB-300001427
- Conditions
- Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of Michigan, University of Witwatersrand, South Africa, University of Pennsylvania, National Institute of Mental Health (NIMH)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.
Detailed description
Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home visits | Active comparator | Behavioral: Home visitsParticipants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker. |
| HIV Self-testing | Active comparator | Behavioral: HIV Self-testingWomen in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points. |
| Standard Care | No intervention | –Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women at 36 weeks of pregnancy or less
- 15 years of age or older
- Has been offered HIV testing at ANC
- Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
- Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
Key exclusion criteria (5 listed)
- Greater than 36 weeks of pregnancy
- Less than 15 years of age
- Not currently in a stable relationship with a male partner
- Does not currently live with male partner
- Has not been offered HIV testing at ANC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visitsIf a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum. | Behavioural | Home visits |
| HIV Self-testingWomen in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained. | Behavioural | HIV Self-testing |
Primary outcome
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum
Time frame: up to 12 months postpartum
Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.
18 secondary outcomes
HIV Re-testing
Time frame: Up to 12 months postpartum
Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)
Time frame: Up to 12 months postpartum
Number of New Discordant Couples (Intervention Arms Only)
Time frame: Up to 12 months postpartum
HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum
Time frame: Up to 18 months postpartum
Women Who Utilized All 4 MCH Services up to 3 Months Postpartum
Time frame: Up to 3 months postpartum
Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline)
Time frame: Up to 18 months postpartum
Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
Time frame: Up to 12 months postpartum
Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up
Time frame: Up to 12 months postpartum
Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up)
Time frame: Up to 12 months postpartum
Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up)
Time frame: Up to 12 months postpartum
Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
Time frame: Up to 12 months postpartum
Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up
Time frame: Up to 12 months postpartum
Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum)
Time frame: Up to 12 months postpartum
Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum)
Time frame: Up to 12 months postpartum
Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)
Time frame: Up to 18 months postpartum
HIV-free Child Survival
Time frame: 18 months after the birth
Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum
Time frame: Up to 18 months after birth
Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up)
Time frame: Up to 18 months after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33407784Kwena Z, Kimbo L, Darbes LA, Hatcher AM, Helova A, Owino G, Thirumurthy H, Bukusi EA, Braun T, Kilgore M, Pisu M, Tamhane A, Nghiem VT, Agot K, Neilands TB, Turan JM. Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):19. doi: 10.1186/s13063-020-04956-1.
- Results publication: PubMed 36709657Borgstede SJ, Elly A, Helova A, Kwena Z, Darbes LA, Hatcher A, Thirumurthy H, Owino G, Pisu M, Owuor K, Braun T, Turan JM, Bukusi EA, Nghiem VT. Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya. Value Health Reg Issues. 2023 Mar;34:125-132. doi: 10.1016/j.vhri.2022.11.003. Epub 2023 Jan 27.
- Derived from this study: PubMed 42372779Turan JM, Kwena ZA, Owuor K, Helova A, Hatcher AM, Braun TM, Owengah E, Okombo M, Nghiem VT, Thirumurthy H, Bukusi EA, Darbes LA. Effectiveness of interventions to promote couples-based HIV testing and family health during pregnancy and postpartum in Kenya: a multicentre, couples-based, randomised controlled trial. Lancet HIV. 2026 Sep;13(9):e631-e642. doi: 10.1016/S2352-3018(26)00104-9. Epub 2026 Jun 29.
- Derived from this study: PubMed 41607089Buyukcan-Tetik A, Ergun TD, Turan B, Mukerji R, Owuor K, Hatcher A, Bukusi EA, Kwena Z, Helova A, Owengah E, Darbes L, Turan JM. HIV-related stigma, couple relationship quality, and mental health in sero-discordant pregnant couples in Kenya. Appl Psychol Health Well Being. 2026 Feb;18(1):e70120. doi: 10.1111/aphw.70120.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet M Turan, PhD, MPH principal investigator
University of Alabama at Birmingham
Lynae Darbes, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visits and HIV Self-testing in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum (time frame: up to 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547739, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.