An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi

NCT ID: NCT06367348

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2028-05-31

Brief 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 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.

Conditions

HIV/AIDS; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Comparison

Standard of care, e.g. regular HIV care plus brief advice on alcohol use

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mlambe Intervention

A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.

Group Type: EXPERIMENTAL

Mlambe

Intervention Type: BEHAVIORAL

A combined economic and relationship-strengthening intervention. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.

Interventions

Mlambe

A combined economic and relationship-strengthening intervention. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. In a married or cohabitating union

2. Have at least one partner with a positive AUDIT-C screen in prior 3 months

3. Must also currently be on ART for at least 6 months

4. Must have disclosed their HIV status to their partner

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Conroy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Invest in Knowledge Initiative (IKI)

Zomba, , Malawi

Site Status: RECRUITING

Countries

Malawi

Central Contacts

James Mkandawire

Role: CONTACT

james3mkandawire@gmail.com

+265 8883 70081

Amy Conroy, PhD

Role: CONTACT

Amy.conroy@ucsf.edu

415-476-6021

Facility Contacts

James Mkandawire

Role: primary

james.mkandawire@investinknowledge.org

Role: backup

0888370081

References

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.

Reference Type: BACKGROUND

PMID: 36520335 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28398134 (View on PubMed)

Conroy 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.

Reference Type: BACKGROUND

PMID: 30218319 (View on PubMed)

Conroy 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.

Reference Type: BACKGROUND

PMID: 31456201 (View on PubMed)

Darbes 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.

Reference Type: BACKGROUND

PMID: 30730356 (View on PubMed)

Ssewamala 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.

Reference Type: BACKGROUND

PMID: 19520472 (View on PubMed)

Bermudez 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.

Reference Type: BACKGROUND

PMID: 29846836 (View on PubMed)

Mkandawire 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.

Reference Type: DERIVED

PMID: 39929508 (View on PubMed)

Other Identifiers

R01AA031445

Identifier Type: NIH

Identifier Source: secondary_id

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R01AA031445

Identifier Type: NIH

Identifier Source: org_study_id

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