HIV/AIDSNCT06367348
An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use 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
With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty… 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
- 500 participants
- Where
- 1 siteMalawi
- Study dates
- 14 Feb 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Must also currently be on ART for at least 6 months
- Must have disclosed their HIV status to their partner
Who cannot join
- 1) 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). Couples who participated in Mlambe's pilot study will also be excluded.
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 Initiative (IKI)
Zomba
James Mkandawire, james.mkandawire@investinknowledge.org
0888370081
About this study
Official title: Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.
Read the detailed description
The inter-related issues of alcohol use, intimate partner violence (IPV), and economic insecurity threaten to derail progress towards UNAIDS 95-95-95 targets in sub-Saharan Africa (SSA). Rates of heavy drinking are alarmingly high among people living with HIV (PLWH), and almost twice that of the general population. Heavy drinking is very common in Malawi, and has deleterious effects on antiretroviral therapy (ART) adherence and HIV clinical outcomes, but also indirectly affects health by damaging the couple relationships needed for social support, economic survival, and well-being. Most alcohol interventions treat heavy drinking as an individual-level issue; however, for people in committed relationships, research suggests an urgent need for interventions that consider alcohol use as a couple-level issue involving both partners. Novel alcohol interventions are paramount for breaking cycles of IPV and poverty, and creating stronger families to prevent HIV, and reduce HIV mortality, morbidity, and transmission. Yet, no interventions to date have jointly addressed the economic and relationship context of drinking alcohol among people living with HIV in SSA, which may have synergistic effects on heavy alcohol use when combined.
To address this gap, the investigators developed and tested Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking. Pilot results showed that Mlambe was feasible and acceptable, and showed promise of efficacy. Given this strong evidence, the investigators will evaluate the efficacy and cost-effectiveness of Mlambe with a full-scale RCT. This is the first RCT of an integrated economic and relationship-strengthening intervention to address alcohol use in HIV-affected couples.
For Aim 1, the primary hypothesis is that the odds of heavy alcohol use will be lower in Mlambe as compared to enhanced usual care (EUC). Secondarily, the investigators expect that Mlambe participants will have a higher odds of ART and appointment adherence, and viral suppression, and lower number of drinking days, AUDIT-C score, and PEth levels. For Aim 2, the investigators hypothesize that Mlambe participants will report greater improvements in relationship dynamics (e.g., better communication, less IPV) as compared to EUC participants.
- 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. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.
| 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.
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 11 months
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 15 months
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 20 months
Secondary outcomes (16)
Viral Suppression measured using whole blood viral load tests
Viral suppression will be defined as a viral load value below the limit of detection of the test.
Measured: 15 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Antiretroviral medication adherence will be measured using the adapted Visual Analog Scale. Scores range from 0-100% adherence. 95% adherence or more will be considered adherent.
Measured: 11 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Antiretroviral medication adherence will be measured using the adapted Visual Analog Scale. Scores range from 0-100% adherence. 95% adherence or more will be considered adherent.
Measured: 15 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Antiretroviral medication adherence will be measured using the adapted Visual Analog Scale. Scores range from 0-100% adherence. 95% adherence or more will be considered adherent.
Measured: 20 months
Medical appointment adherence assessment
Appointment adherence will be defined as no missed HIV care visits in the past 3 months.
Measured: 11 months
Medical appointment adherence assessment
Appointment adherence will be defined as no missed HIV care visits in the past 3 months.
Measured: 15 months
Medical appointment adherence assessment
Appointment adherence will be defined as no missed HIV care visits in the past 3 months.
Measured: 20 months
Number of drinking days measured using the "Timeline follow-back" method
Number of drinking days in the past 30 days will be measured using the "timeline follow-back" method. Value Range from 0-30. Higher numbers indicate more drinking days.
Measured: 11 months
Number of drinking days measured using the "Timeline follow-back" method
Number of drinking days in the past 30 days will be measured using the "timeline follow-back" method. Value Range from 0-30. Higher numbers indicate more drinking days.
Measured: 15 months
Number of drinking days measured using the "Timeline follow-back" method
Number of drinking days in the past 30 days will be measured using the "timeline follow-back" method. Value Range from 0-30. Higher numbers indicate more drinking days.
Measured: 20 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
The three item Alcohol Use Disorders Identification Test (Audit-C) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking (continuous variable)
Measured: 11 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
The three item Alcohol Use Disorders Identification Test (Audit-C) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking (continuous variable)
Measured: 15 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
The three item Alcohol Use Disorders Identification Test (Audit-C) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking (continuous variable)
Measured: 20 months
PEth level measured using a Phosphatidylethanol biomarker test
The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 11 months
PEth level measured using a Phosphatidylethanol biomarker test
The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 15 months
PEth level measured using a Phosphatidylethanol biomarker test
The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start14 Feb 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 500 participants (estimated)
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)
- Responsible party
- Sponsor
- Investigators
- Amy Conroy, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367348
- Sponsor's protocol ID
- R01AA031445
- Other IDs
- R01AA031445
- Status last verified
- May 2026
- First submitted
- 10 Apr 2024
- Last updated
- 14 May 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 National Institute on Alcohol Abuse and Alcoholism (NIAAA) sponsored data repository, the NIAAA Data Archive (NIAAADA), a controlled access public repository. The NIAAADA is housed within the NIMH Data Archive (NDA).
Publications
Conroy AA, Tebbetts S, Darbes LA, Hahn JA, Neilands TB, McKenna SA, Mulauzi N, Mkandawire J, Ssewamala FM. Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi. AIDS Behav. 2023 Jul;27(7):2255-2270. doi: 10.1007/s10461-022-03956-3. Epub 2022 Dec 15.
PubMed 36520335Conroy 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 29846836Mkandawire J, Ssewamala FM, Hahn JA, Mulauzi N, Neilands TB, Tebbetts S, Darbes LA, Brown DS, Conroy AA. Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe. BMJ Open. 2025 Feb 10;15(2):e097247. doi: 10.1136/bmjopen-2024-097247.
PubMed 39929508
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
- ClinicalTrials.gov ID
- NCT06367348
- Acronym / sponsor ID
- R01AA031445
- Conditions
- HIV/AIDS, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.
Detailed description
The inter-related issues of alcohol use, intimate partner violence (IPV), and economic insecurity threaten to derail progress towards UNAIDS 95-95-95 targets in sub-Saharan Africa (SSA). Rates of heavy drinking are alarmingly high among people living with HIV (PLWH), and almost twice that of the general population. Heavy drinking is very common in Malawi, and has deleterious effects on antiretroviral therapy (ART) adherence and HIV clinical outcomes, but also indirectly affects health by damaging the couple relationships needed for social support, economic survival, and well-being. Most alcohol interventions treat heavy drinking as an individual-level issue; however, for people in committed relationships, research suggests an urgent need for interventions that consider alcohol use as a couple-level issue involving both partners. Novel alcohol interventions are paramount for breaking cycles of IPV and poverty, and creating stronger families to prevent HIV, and reduce HIV mortality, morbidity, and transmission. Yet, no interventions to date have jointly addressed the economic and relationship context of drinking alcohol among people living with HIV in SSA, which may have synergistic effects on heavy alcohol use when combined.
To address this gap, the investigators developed and tested Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking. Pilot results showed that Mlambe was feasible and acceptable, and showed promise of efficacy. Given this strong evidence, the investigators will evaluate the efficacy and cost-effectiveness of Mlambe with a full-scale RCT. This is the first RCT of an integrated economic and relationship-strengthening intervention to address alcohol use in HIV-affected couples.
For Aim 1, the primary hypothesis is that the odds of heavy alcohol use will be lower in Mlambe as compared to enhanced usual care (EUC). Secondarily, the investigators expect that Mlambe participants will have a higher odds of ART and appointment adherence, and viral suppression, and lower number of drinking days, AUDIT-C score, and PEth levels. For Aim 2, the investigators hypothesize that Mlambe participants will report greater improvements in relationship dynamics (e.g., better communication, less IPV) as compared to EUC participants.
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 (4 listed)
- In a married or cohabitating union
- Have at least one partner with a positive AUDIT-C screen in prior 3 months
- Must also currently be on ART for at least 6 months
- Must have disclosed their HIV status to their partner
Key exclusion criteria (1 listed)
- 1) 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). Couples who participated in Mlambe's pilot study will also be excluded.
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. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication. | Behavioural | Mlambe Intervention |
Primary outcome
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
Time frame: 11 months
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
Time frame: 15 months
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
Time frame: 20 months
The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.
16 secondary outcomes
Viral Suppression measured using whole blood viral load tests
Time frame: 15 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Time frame: 11 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Time frame: 15 months
Antiretroviral medication adherence measured using a Visual Analog Scale
Time frame: 20 months
Medical appointment adherence assessment
Time frame: 11 months
Medical appointment adherence assessment
Time frame: 15 months
Medical appointment adherence assessment
Time frame: 20 months
Number of drinking days measured using the "Timeline follow-back" method
Time frame: 11 months
Number of drinking days measured using the "Timeline follow-back" method
Time frame: 15 months
Number of drinking days measured using the "Timeline follow-back" method
Time frame: 20 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
Time frame: 11 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
Time frame: 15 months
AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
Time frame: 20 months
PEth level measured using a Phosphatidylethanol biomarker test
Time frame: 11 months
PEth level measured using a Phosphatidylethanol biomarker test
Time frame: 15 months
PEth level measured using a Phosphatidylethanol biomarker test
Time frame: 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 36520335Conroy AA, Tebbetts S, Darbes LA, Hahn JA, Neilands TB, McKenna SA, Mulauzi N, Mkandawire J, Ssewamala FM. Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi. AIDS Behav. 2023 Jul;27(7):2255-2270. doi: 10.1007/s10461-022-03956-3. Epub 2022 Dec 15.
- 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 39929508Mkandawire J, Ssewamala FM, Hahn JA, Mulauzi N, Neilands TB, Tebbetts S, Darbes LA, Brown DS, Conroy AA. Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe. BMJ Open. 2025 Feb 10;15(2):e097247. doi: 10.1136/bmjopen-2024-097247.
- Individual participant dataSharing planned: 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 National Institute on Alcohol Abuse and Alcoholism (NIAAA) sponsored data repository, the NIAAA Data Archive (NIAAADA), a controlled access public repository. The NIAAADA is housed within the NIMH Data Archive (NDA).
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
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 4 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Mkandawire (+265 8883 70081, james3mkandawire@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test (time frame: 11 months). The study lists 3 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 NCT06367348, 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 14 May 2026.