HIV/AIDSNCT04906616
An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
A study testing Mlambe in people with HIV/AIDS and Alcohol Abuse, run by University of California, San Francisco at 1 site in Malawi.
Trial summary
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Alcohol Abuse
- What is being tested?
- Mlambe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteMalawi
- Study dates
- 31 May 2021to 13 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in a married or cohabitating union
- have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner
Who cannot join
- severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
Trial locations and contacts
1 site in 1 country.
About this study
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.
Read the detailed description
This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.
- Conditions
- HIV/AIDS, Alcohol Abuse
- Being tested
- Mlambe
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MlambeBehavioural
A combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART.
| Study group | Role | What they receive |
|---|---|---|
| Control Comparison | No intervention | Standard of care, e.g. regular HIV care plus brief advice on alcohol use |
| Mlambe Intervention | Experimental | A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Receives: Behavioral: Mlambe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Percentage of eligible couples enrolled in the study.
Measured: Baseline (Time 0)
Retention Rate
Percentage of enrolled and randomized participants retained at the end of the study
Measured: 15 months
Secondary outcomes (6)
Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months
Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 10 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.
Measured: 10 months
Percentage of Couples Who Are Satisfied With the Intervention at 15 Months
Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 15 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.
Measured: 15 months
10 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 10 months
Measured: 10 months
15 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 15 months
Measured: 15 months
75% Intervention Completion
Percentage of couples who attend 75% of intervention sessions
Measured: 10 months
100% Intervention Completion
Percentage of couples who attend 100% of intervention sessions
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start31 May 2021
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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 (8)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Invest in Knowledge Initiative (IKI) - Zomba, Malawi, University of Michigan, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Amy Conroy, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906616
- Sponsor's protocol ID
- P0535590
- Other IDs
- R34AA027983-01
- Status last verified
- Jan 2024
- First submitted
- 25 May 2021
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conroy A, Leddy A, Johnson M, Ngubane T, van Rooyen H, Darbes L. 'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples. Cult Health Sex. 2017 Nov;19(11):1239-1253. doi: 10.1080/13691058.2017.1309460. Epub 2017 Apr 11.
PubMed 28398134Conroy AA, McKenna SA, Ruark A. Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi. AIDS Behav. 2019 Jan;23(1):201-210. doi: 10.1007/s10461-018-2275-2.
PubMed 30218319Conroy AA, Ruark A, McKenna SA, Tan JY, Darbes LA, Hahn JA, Mkandawire J. The Unaddressed Needs of Alcohol-Using Couples on Antiretroviral Therapy in Malawi: Formative Research on Multilevel Interventions. AIDS Behav. 2020 Jun;24(6):1599-1611. doi: 10.1007/s10461-019-02653-y.
PubMed 31456201Darbes LA, McGrath NM, Hosegood V, Johnson MO, Fritz K, Ngubane T, van Rooyen H. Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):404-413. doi: 10.1097/QAI.0000000000001948.
PubMed 30730356Ssewamala FM, Han CK, Neilands TB. Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda. Soc Sci Med. 2009 Jul;69(2):191-8. doi: 10.1016/j.socscimed.2009.05.019. Epub 2009 Jun 10.
PubMed 19520472Bermudez LG, Ssewamala FM, Neilands TB, Lu L, Jennings L, Nakigozi G, Mellins CA, McKay M, Mukasa M. Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda. AIDS Behav. 2018 Nov;22(11):3763-3772. doi: 10.1007/s10461-018-2173-7.
PubMed 29846836Gopalakrishnan L, Mulauzi N, Mkandawire J, Ssewamala FM, Tebbetts S, Neilands TB, Conroy AA. Effects of economic empowerment and relationship strengthening intervention on financial behaviors among couples living with HIV: The Mlambe pilot trial in Malawi. SSM Popul Health. 2025 Feb 25;29:101768. doi: 10.1016/j.ssmph.2025.101768. eCollection 2025 Mar.
PubMed 40104040Conroy AA, Ruark A, Mulauzi N, Mkandawire J, Darbes LA, Hahn JA, Neilands TB, Tebbetts S, Ssewamala FM. Mlambe economic and relationship-strengthening intervention for alcohol use decreases violence and improves relationship quality in couples living with HIV in Malawi. Soc Sci Med. 2024 Dec;362:117407. doi: 10.1016/j.socscimed.2024.117407. Epub 2024 Oct 9.
PubMed 39405663
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
- ClinicalTrials.gov ID
- NCT04906616
- Acronym / sponsor ID
- P0535590
- Conditions
- HIV/AIDS, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Invest in Knowledge Initiative (IKI) - Zomba, Malawi, University of Michigan, Washington University School of Medicine
- Study start
- 31 May 2021 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.
Detailed description
This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Couples will be randomized 1:1 to intervention or control arm
| Arm | Type | Receives |
|---|---|---|
| Control Comparison | No intervention | –Standard of care, e.g. regular HIV care plus brief advice on alcohol use |
| Mlambe Intervention | Experimental | Behavioral: MlambeA couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- in a married or cohabitating union
- have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner
Key exclusion criteria (1 listed)
- severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
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 |
|---|---|---|
| MlambeA combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. | Behavioural | Mlambe Intervention |
Primary outcome
Enrollment Rate
Time frame: Baseline (Time 0)
Percentage of eligible couples enrolled in the study.
Retention Rate
Time frame: 15 months
Percentage of enrolled and randomized participants retained at the end of the study
6 secondary outcomes
Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months
Time frame: 10 months
Percentage of Couples Who Are Satisfied With the Intervention at 15 Months
Time frame: 15 months
10 Month Follow up Survey Completion
Time frame: 10 months
15 Month Follow up Survey Completion
Time frame: 15 months
75% Intervention Completion
Time frame: 10 months
100% Intervention Completion
Time frame: 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28398134Conroy A, Leddy A, Johnson M, Ngubane T, van Rooyen H, Darbes L. 'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples. Cult Health Sex. 2017 Nov;19(11):1239-1253. doi: 10.1080/13691058.2017.1309460. Epub 2017 Apr 11.
- Background: PubMed 30218319Conroy AA, McKenna SA, Ruark A. Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi. AIDS Behav. 2019 Jan;23(1):201-210. doi: 10.1007/s10461-018-2275-2.
- Background: PubMed 31456201Conroy AA, Ruark A, McKenna SA, Tan JY, Darbes LA, Hahn JA, Mkandawire J. The Unaddressed Needs of Alcohol-Using Couples on Antiretroviral Therapy in Malawi: Formative Research on Multilevel Interventions. AIDS Behav. 2020 Jun;24(6):1599-1611. doi: 10.1007/s10461-019-02653-y.
- Background: PubMed 30730356Darbes LA, McGrath NM, Hosegood V, Johnson MO, Fritz K, Ngubane T, van Rooyen H. Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):404-413. doi: 10.1097/QAI.0000000000001948.
- Background: PubMed 19520472Ssewamala FM, Han CK, Neilands TB. Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda. Soc Sci Med. 2009 Jul;69(2):191-8. doi: 10.1016/j.socscimed.2009.05.019. Epub 2009 Jun 10.
- Background: PubMed 29846836Bermudez LG, Ssewamala FM, Neilands TB, Lu L, Jennings L, Nakigozi G, Mellins CA, McKay M, Mukasa M. Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda. AIDS Behav. 2018 Nov;22(11):3763-3772. doi: 10.1007/s10461-018-2173-7.
- Derived from this study: PubMed 40104040Gopalakrishnan L, Mulauzi N, Mkandawire J, Ssewamala FM, Tebbetts S, Neilands TB, Conroy AA. Effects of economic empowerment and relationship strengthening intervention on financial behaviors among couples living with HIV: The Mlambe pilot trial in Malawi. SSM Popul Health. 2025 Feb 25;29:101768. doi: 10.1016/j.ssmph.2025.101768. eCollection 2025 Mar.
- Derived from this study: PubMed 39405663Conroy AA, Ruark A, Mulauzi N, Mkandawire J, Darbes LA, Hahn JA, Neilands TB, Tebbetts S, Ssewamala FM. Mlambe economic and relationship-strengthening intervention for alcohol use decreases violence and improves relationship quality in couples living with HIV in Malawi. Soc Sci Med. 2024 Dec;362:117407. doi: 10.1016/j.socscimed.2024.117407. Epub 2024 Oct 9.
- 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.
Amy Conroy, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mlambe in people with HIV/AIDS and Alcohol Abuse, run by University of California, San Francisco at 1 site in Malawi.
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 2 inclusion and 1 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 20 Feb 2024. 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 Malawi. 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 20 Feb 2024). 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?
Enrollment Rate (time frame: Baseline (Time 0)). The study lists 2 primary outcomes in all. 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 NCT04906616, which also lists 8 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 20 Feb 2024.