Trial Outcomes & Findings for An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi (NCT NCT04906616)

Results Overview

Percentage of eligible couples enrolled in the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

Baseline (Time 0)

Results posted on

2024-02-20

Participant Flow

The values in the data table represent individual participants and not couples.

Participant milestones

Participant milestones
Measure	Control Comparison Standard of care, e.g. regular HIV care plus brief advice on alcohol use	Mlambe Intervention A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Overall Study STARTED	78	78
Overall Study COMPLETED	75	76
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Comparison Standard of care, e.g. regular HIV care plus brief advice on alcohol use	Mlambe Intervention A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Overall Study Divorce	3	2

Baseline Characteristics

An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Comparison n=78 Participants Standard of care, e.g. regular HIV care plus brief advice on alcohol use	Mlambe Intervention n=78 Participants A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.	Total n=156 Participants Total of all reporting groups
Age, Continuous	43.7 Years STANDARD_DEVIATION 10.3 • n=93 Participants	43.2 Years STANDARD_DEVIATION 10.1 • n=4 Participants	43.4 Years STANDARD_DEVIATION 10.2 • n=27 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	39 Participants n=4 Participants	78 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	39 Participants n=4 Participants	78 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	78 Participants n=93 Participants	78 Participants n=4 Participants	156 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Malawi	78 participants n=93 Participants	78 participants n=4 Participants	156 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Time 0)

Population: 89 couples were screened as eligible for inclusion in the study. 84 couples completed baseline assessments. 78 couples (156 participants) were randomized into the study: 39 couples into the control arm and 39 couples into the intervention arm.

Percentage of eligible couples enrolled in the study.

Outcome measures

Outcome measures
Measure	Enrollment Rate n=89 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Enrollment Rate	84 couples	—

PRIMARY outcome

Timeframe: 15 months

Percentage of enrolled and randomized participants retained at the end of the study

Outcome measures

Outcome measures
Measure	Enrollment Rate n=78 Participants Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=78 Participants A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Retention Rate	75 Participants	76 Participants

SECONDARY outcome

Timeframe: 10 months

Population: This count here is for couples, not individuals.

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months	39 couples	39 couples

SECONDARY outcome

Timeframe: 15 months

Population: The units analyzed are for couples (not individuals)

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.

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
Percentage of Couples Who Are Satisfied With the Intervention at 15 Months	39 couples	39 couples

SECONDARY outcome

Timeframe: 10 months

Percentage of couples who complete follow up surveys at 10 months

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
10 Month Follow up Survey Completion	36 couples	38 couples

SECONDARY outcome

Timeframe: 15 months

Percentage of couples who complete follow up surveys at 15 months

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
15 Month Follow up Survey Completion	37 couples	37 couples

SECONDARY outcome

Timeframe: 10 months

Percentage of couples who attend 75% of intervention sessions

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
75% Intervention Completion	39 couples	39 couples

SECONDARY outcome

Timeframe: 10 months

Percentage of couples who attend 100% of intervention sessions

Outcome measures

Outcome measures
Measure	Enrollment Rate n=39 couples Percentage of eligible couples who completed baseline assessments.	Mlambe Intervention n=39 couples A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. Mlambe: 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.
100% Intervention Completion	39 couples	39 couples

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 months, 15 months

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Conroy

University of California, San Francisco

Phone: 415-476-6021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place