Alcohol Abuse, HIV/AIDS
Conditions
Brief summary
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.
Interventions
BEHAVIORALMlambe
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Invest in Knowledge Initiative (IKI) - Zomba, Malawi
University of Michigan
Washington University School of Medicine
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Couples will be randomized 1:1 to intervention or control arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 15 months | Percentage of enrolled and randomized participants retained at the end of the study |
| Enrollment Rate | Baseline (Time 0) | Percentage of eligible couples enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Couples Who Are Satisfied or Very Satisfied With the Intervention at 10 Months | 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. |
| Percentage of Couples Who Are Satisfied With the Intervention at 15 Months | 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. |
| 100% Intervention Completion | 10 months | Percentage of couples who attend 100% of intervention sessions |
| 10 Month Follow up Survey Completion | 10 months | Percentage of couples who complete follow up surveys at 10 months |
| 15 Month Follow up Survey Completion | 15 months | Percentage of couples who complete follow up surveys at 15 months |
| 75% Intervention Completion | 10 months | Percentage of couples who attend 75% of intervention sessions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: Alcohol Use | 10 months, 15 months | Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method |
| Exploratory: Viral Suppression | 10 months, 15 months | Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS) |
| Exploratory: ART Adherence | 10 months, 15 months | Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS |
Countries
Malawi
Participant flow
Pre-assignment details
The values in the data table represent individual participants and not couples.
Participants by arm
| Arm | Count |
|---|---|
| Control Comparison Standard of care, e.g. regular HIV care plus brief advice on alcohol use | 78 |
| 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. | 78 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Divorce | 3 | 2 |
Baseline characteristics
| Characteristic | Control Comparison | Total | Mlambe Intervention |
|---|---|---|---|
| Age, Continuous | 43.7 Years STANDARD_DEVIATION 10.3 | 43.4 Years STANDARD_DEVIATION 10.2 | 43.2 Years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants | 156 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Malawi | 78 participants | 156 participants | 78 participants |
| Sex: Female, Male Female | 39 Participants | 78 Participants | 39 Participants |
| Sex: Female, Male Male | 39 Participants | 78 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 1 / 78 |
| other Total, other adverse events | 0 / 78 | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 | 0 / 78 |
Outcome results
Primary
Enrollment Rate
Percentage of eligible couples enrolled in the study.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | Enrollment Rate | 84 couples |
Primary
Retention Rate
Percentage of enrolled and randomized participants retained at the end of the study
Time frame: 15 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrollment Rate | Retention Rate | 75 Participants |
| Mlambe Intervention | Retention Rate | 76 Participants |
Secondary
100% Intervention Completion
Percentage of couples who attend 100% of intervention sessions
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | 100% Intervention Completion | 39 couples |
| Mlambe Intervention | 100% Intervention Completion | 39 couples |
Secondary
10 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 10 months
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | 10 Month Follow up Survey Completion | 36 couples |
| Mlambe Intervention | 10 Month Follow up Survey Completion | 38 couples |
Secondary
15 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 15 months
Time frame: 15 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | 15 Month Follow up Survey Completion | 37 couples |
| Mlambe Intervention | 15 Month Follow up Survey Completion | 37 couples |
Secondary
75% Intervention Completion
Percentage of couples who attend 75% of intervention sessions
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | 75% Intervention Completion | 39 couples |
| Mlambe Intervention | 75% Intervention Completion | 39 couples |
Secondary
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.
Time frame: 10 months
Population: This count here is for couples, not individuals.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | Percentage of Couples Who Are Satisfied or Very Satisfied With the Intervention at 10 Months | 39 couples |
| Mlambe Intervention | Percentage of Couples Who Are Satisfied or Very Satisfied With the Intervention at 10 Months | 39 couples |
Secondary
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.
Time frame: 15 months
Population: The units analyzed are for couples (not individuals)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrollment Rate | Percentage of Couples Who Are Satisfied With the Intervention at 15 Months | 39 couples |
| Mlambe Intervention | Percentage of Couples Who Are Satisfied With the Intervention at 15 Months | 39 couples |
Other Pre-specified
Exploratory: Alcohol Use
Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method
Time frame: 10 months, 15 months
Other Pre-specified
Exploratory: Alcohol Use
Non-heavy drinking determined by self-report (Alcohol Use Disorders Identification Test - Consumption \[AUDIT-C\], prior 3 months, negative) and phosphatidylethanol (PEth) \<35 ng/mL (composite measure)
Time frame: 10 months, 15 months
Other Pre-specified
Exploratory: ART Adherence
Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Time frame: 10 months, 15 months
Other Pre-specified
Exploratory: Viral Suppression
Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time frame: 10 months, 15 months