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

HIV/AIDS Clinical Trial

Official title:

Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367348
• Other study ID #: R01AA031445
• Secondary ID: R01AA031445
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: May 2028

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: James Mkandawire
• Phone: +265 8883 70081
• Email: james3mkandawire[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
Malawi	Invest in Knowledge Initiative (IKI)	Zomba

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

Malawi, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.	The Communications Pattern Questionnaire (CPQ) assesses communication styles and patterns within relationships. Mutually constructive communication consists of three items. Scores can range from 3-15 using a 5 point Likert scale. Higher scores indicate more constructive communication.	11 months
Other	Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.	The Communications Pattern Questionnaire (CPQ) assesses communication styles and patterns within relationships. Mutually constructive communication consists of three items. Scores can range from 3-15 using a 5 point Likert scale. Higher scores indicate more constructive communication.	15 months
Other	Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.	The Communications Pattern Questionnaire (CPQ) assesses communication styles and patterns within relationships. Mutually constructive communication consists of three items. Scores can range from 3-15 using a 5 point Likert scale. Higher scores indicate more constructive communication.	20 months
Other	Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.	Measure adapted from the HIV-specific Partner Support Scale. Scores can range from 9-45 using a 5 point Likert scale (9 variables). Higher scores indicate higher alcohol specific partner support.	11 months
Other	Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.	Measure adapted from the HIV-specific Partner Support Scale. Scores can range from 9-45 using a 5 point Likert scale (9 variables). Higher scores indicate higher alcohol specific partner support.	15 months
Other	Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.	Measure adapted from the HIV-specific Partner Support Scale. Scores can range from 9-45 using a 5 point Likert scale (9 variables). Higher scores indicate higher alcohol specific partner support.	20 months
Other	Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)	Items adapted from the World Health Organization Domestic Violence module and the Malawi Demographic and Health Survey. Physical, sexual, and emotional IPV is captured. Three response items per variable (Never, Sometimes, Frequently). Higher scores indicate higher levels of IPV.	11 months
Other	Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)	Items adapted from the World Health Organization Domestic Violence module and the Malawi Demographic and Health Survey. Physical, sexual, and emotional IPV is captured. Three response items per variable (Never, Sometimes, Frequently). Higher scores indicate higher levels of IPV.	15 months
Other	Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)	Items adapted from the World Health Organization Domestic Violence module and the Malawi Demographic and Health Survey. Physical, sexual, and emotional IPV is captured. Three response items per variable (Never, Sometimes, Frequently). Higher scores indicate higher levels of IPV.	20 months
Primary	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.	11 months
Primary	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.	15 months
Primary	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.	20 months
Secondary	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.	15 months
Secondary	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.	11 months
Secondary	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.	15 months
Secondary	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.	20 months
Secondary	Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	11 months
Secondary	Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	15 months
Secondary	Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	20 months
Secondary	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.	11 months
Secondary	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.	15 months
Secondary	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.	20 months
Secondary	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)	11 months
Secondary	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)	15 months
Secondary	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)	20 months
Secondary	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.	11 months
Secondary	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.	15 months
Secondary	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.	20 months