HIV Antiretroviral Therapy (ART) AdherenceNCT06659315
Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
A study testing Couples Problem Solving Therapy in people with HIV Antiretroviral Therapy (ART) Adherence and Perinatal Mental Health, run by University of California, San Francisco at 1 site in Malawi.
Trial summary
Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health, Depression During Pregnancy
- What is being tested?
- Couples Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteMalawi
- Study dates
- 11 Nov 2025to 1 Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In a marriage or cohabitating union for at least 6 months.
- One member of the couple is a woman in the second or third trimester of pregnancy who is living with HIV and screens positive for depression (>10 on the PHQ9).
- Have revealed their HIV status to their partner if living with HIV>
Who cannot join
- Fear their safety would be at risk.
- Report incidents of severe intimate partner violence (IPV) in the past three months using the WHO IPV measure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Invest in Knowledge (IKI)
Zomba
James Mkandawire, MPH
Nancy Mulauzi, 265 (0) 888370081, nancy.mulauzi@gmail.com
About this study
Official title: Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach
Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food/economic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.
Read the detailed description
Although prevention of mother-to-child transmission of HIV (PMTCT) services are widely available, 140,000 infants contracted HIV in 2021 and the majority were in sub-Saharan Africa (SSA). Urgent attention is needed to address poor engagement in PMTCT care with more than half of mothers disengaged from care by six months postpartum. Perinatal depression (PD) is a robust predictor of poor engagement in HIV care and suboptimal PMTCT adherence-defined as adherence to antiretroviral therapy (ART), infant prophylaxis and testing, and exclusive breastfeeding. Few PD interventions have been developed to address PMTCT in SSA and none have involved male partners, who are often major sources of financial and emotional support. Nor have interventions targeted the couple dynamics that can influence the mother's experience of PD and ability to access PMTCT. This project aims to fill this gap by developing and evaluating a problem-solving therapy (PST) intervention with perinatal women and their male partners to reduce PD symptoms and improve adherence to PMTCT in Malawi.
Pregnancy and postpartum are challenging times for couples with the stress of a new child, rising food expenses and nutritional demands, potential for couple conflict with new stressors, and less opportunity for connection and intimacy-all of which are amplified in the presence of PD. Among perinatal women with HIV in Kenya, investigators found that women's mental health and adherence to PMTCT was worsened by intimate partner violence (IPV) but positively affected by social support from partners, including food support during pregnancy and the breastfeeding period. In Malawi, investigators found that women in higher functioning relationships (e.g., better intimacy, communication) reported lower levels of depression, whereas women who reported IPV had higher rates of depression. Together, this suggests that dyadic processes such as support, conflict, and communication are central for women's experience of depression and for PMTCT. However, most PD interventions have focused on women alone rather than the dyad, which may explain why half of women treated for PD have reoccurring symptoms.
In this study, the investigators propose a couple-based intervention to strengthen couple relationships and support for partners to work together around depression, food insecurity, and PMTCT. Because food insecurity was the most significant problem for women with PD in the formative work, the investigators believe interventions will be most effective if couples can also engage in problem-solving around nutrition, meal preparation, and access to food.
The investigators propose to build on the World Health Organization (WHO) Problem Management Plus (PM+) intervention, which is based on problem-solving therapy (PST) and is effective at reducing depressive symptoms with individuals. PM+ has been adapted for the Malawi context and is currently undergoing an implementation evaluation. The investigators will adapt PM+ for couples with the goal of engaging partners to provide social support for PD, helping women brainstorm and solve problems around PD, food insecurity, and PMTCT adherence, and improving couple communication skills to help couples talk constructively about depression, nutrition and other needs, relationship challenges, and adherence to PMTCT.
- Conditions
- HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health, Depression During Pregnancy, PMTCT
- Being tested
- Couples Problem Solving Therapy
- Keywords
- Perinatal depression, Couples, Problem-solving, PMTCT, ART adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Problem Solving TherapyBehavioural
A couples-based problem solving program to deal with depression, PMTCT adherence, and couple communication.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | Standard of care, e.g., regular HIV care, regular perinatal care, referrals to services for depression |
| Couple-based problem solving | Experimental | A couples-based intervention to support perinatal women who are experience symptoms of depression. We will adapt the WHO Problem Management Plus manual for this study. There are 5 sessions that deal with stress management, problem-solving, behavioral activation, and skills to strengthen social support. The final session will be modified to enhance couple communication skills. Because many of our participants will be dealing with food scarcity, we will develop a priori strategies to help couple brainstorm dealing with this issue. Receives: Behavioral: Couples Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in the intervention
Proportion of couples who attend 75% and 100% of sessions.
Measured: following the intervention period, an average of 5 months
Retention
Proportion of couples who complete the study follow-up surveys at 3 months post-partum and 6 months post-partum
Measured: through study completion, an average of 11 months
Intervention fidelity
Study managers will listen to audio recordings of the intervention sessions and complete checklists to assess whether or not each session component was completed.
Measured: following the intervention period, an average of 5 months
Acceptability
Proportion of couples who report satisfaction with the intervention and proportion who would recommend the intervention to friends and neighbors
Measured: Assessed at the 3-month post-partum follow-up
Secondary outcomes (9)
Perinatal depression
Using the Center for Epidemiologic Studies Depression Scale (CES-D scale), which is validated for people living with HIV in SSA. Scores range from 0 to 60 with higher scores indicating more depression symptomatology.
Measured: 3 months post partum
Perinatal depression
Using the Center for Epidemiologic Studies Depression Scale (CES-D scale), which is validated for people living with HIV in SSA. Scores range from 0 to 60 with higher scores indicating more depression symptomatology.
Measured: 6 months post-partum
Perinatal viral suppression
This is a component of PMTCT. The lab at Zomba Central Hospital will use plasma samples to measure viral load.
Measured: 6 months post-partum
Perinatal adherence to ART
This is a component of PMTCT. Using the Visual Analog Scale (VAS), women will report the proportion of prescribed ART doses taken during pregnancy and postpartum. Adherence will be defined as taking 100% of the prescribed medication during each time period.
Measured: 3 months post-partum
Perinatal adherence to ART
This is a component of PMTCT. Using the Visual Analog Scale (VAS), women will report the proportion of prescribed ART doses taken during pregnancy and postpartum. Adherence will be defined as taking 100% of the prescribed medication during each time period.
Measured: 6 months post-partum
Adherence to infant prophylaxis
This is a component of PMTCT. Women will be asked if they ingested Nevirapine (NVP) during labor and delivery (yes or no). Using the Visual Analog Scale (VAS), women will estimate adherence to NVP prophylaxis for the infant postpartum. Higher scores indicated better adherence.
Measured: 3 months post-partum
Infant HIV testing
This is a component of PMTCT. Women will self-report whether they tested their infant for HIV after 8 weeks and the result of test (to be confirmed with medical records).
Measured: 3 months post-partum
Breast feeding
This is a component of adherence to PMTCT. Women will be asked, "Are you currently exclusively breastfeeding your baby?"
Measured: 3 months post-partum
Breast feeding
This is a component of adherence to PMTCT. Women will be asked, "Are you currently exclusively breastfeeding your baby?"
Measured: 6 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 posted26 Oct 2024
- Study start11 Nov 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV Antiretroviral Therapy (ART) AdherenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples will be randomized 1:1 to intervention or control arm
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Invest in Knowledge Initiative (IKI) - Zomba, Malawi
- Responsible party
- Sponsor
- Investigators
- Amy Conroy, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659315
- Sponsor's protocol ID
- 23-40685
- Other IDs
- R34MH134725
- Status last verified
- Mar 2026
- First submitted
- 16 Oct 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will include self-reported demographic and behavioral data from surveys and laboratory data from blood specimens. Individual-participant level or IPD data will be shared. The data will be made in a de-identified format. In addition to the IPD dataset, the researcher will share the data dictionary and final protocol with amendments. Identifiable data will be de-identified prior to repository submission. All participant-level data will be preserved and shared through deposition in the NIMH Data Archive (NDA), a controlled access public repository.
Publications
Bengtson AM, Filipowicz TR, Mphonda S, Udedi M, Kulisewa K, Meltzer-Brody S, Gaynes BN, Go VF, Chibanda D, Verhey R, Hosseinipour MC, Pence BW. An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial. AIDS Behav. 2023 Nov;27(11):3559-3570. doi: 10.1007/s10461-023-04070-8. Epub 2023 Apr 21.
PubMed 37084104Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.
PubMed 15978928Tuthill EL, Neilands TB, Johnson MO, Sauceda J, Mkandawire J, Conroy AA. A Dyadic Investigation of Relationship Dynamics and Depressive Symptoms in HIV-Affected Couples in Malawi. AIDS Behav. 2019 Dec;23(12):3435-3443. doi: 10.1007/s10461-019-02583-9.
PubMed 31273489Coleman SF, Mukasakindi H, Rose AL, Galea JT, Nyirandagijimana B, Hakizimana J, Bienvenue R, Kundu P, Uwimana E, Uwamwezi A, Contreras C, Rodriguez-Cuevas FG, Maza J, Ruderman T, Connolly E, Chalamanda M, Kayira W, Kazoole K, Kelly KK, Wilson JH, Houde AA, Magill EB, Raviola GJ, Smith SL. Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi. Intervention (Amstelveen). 2021 Jan-Jun;19(1):58-66. Epub 2021 Mar 31.
PubMed 34642580Conroy AA, Butterfield RM, Mkandawire J, Mulauzi N, Bengtson AM, Neilands TB, Weiser SD, Johnson MO. Couples problem-solving therapy for perinatal women living with HIV and male partners in Malawi: a study protocol for a pilot trial of Mphatso. BMJ Open. 2026 May 15;16(5):e115210. doi: 10.1136/bmjopen-2025-115210.
PubMed 42152436