Alcohol Abuse, HIV/AIDS
Conditions
Brief summary
This project aims to develop and pilot test an intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to reduce heavy alcohol use with couples living with HIV in South Africa.
Detailed description
This project aims to develop and test an alcohol intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to build dyadic support around drinking in HIV-affected couples in South Africa. Specifically, the study aims to: 1) To develop a couple-based MI intervention with mobile breathalyzer technology to deliver real-time feedback on BAC levels. We will target heavy alcohol users with HIV and enroll their primary partner; 2) to develop and pilot test the study procedures for a future randomized controlled trial (RCT) of the couple-based intervention; and 3) to determine the feasibility and acceptability (F&A) of couple-based MI as a standalone intervention and when combined with mobile breathalyzers to provide real-time feedback and support to couples. We will also conduct qualitative interviews with a subset of 15 couples to contextualize F&A data and refine our procedures. Our goal is to demonstrate a proof-of-concept for the proposed intervention, which if shown to be feasible and acceptable, may provide a scalable intervention to reduce heavy alcohol consumption and improve HIV treatment outcomes for couples in South Africa.
Interventions
BEHAVIORALMotivational Interviewing
Counseling
BEHAVIORALMotivational Interviewing plus Breathalyzer
Counseling plus mobile breathalyzer/ app
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The City College of New York
Human Sciences Research Council
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* in a primary relationship for at least 6 months * aged 18-49 * have at least one partner (the index patient) with a positive AUDIT-C screen score * has been on antiretroviral therapy (ART) for at least 6 months * has disclosed HIV status to their partner
Exclusion criteria
* Report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Baseline (Time 0) | Number of eligible individuals who enroll in the study |
| Retention Rate | 6 months | Number of enrolled individuals who completed the final follow-up survey (6-months post baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final Survey Completion | 6 months | number of couples who complete the six-month survey |
| Number of Participants Who Attended All Intervention Sessions | 2 months | Number of participants who attend all three intervention sessions |
| 70% Breathalyzer Completion | 2 months | number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests |
| Exploratory: ART Adherence | 6 months | Percentage of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS |
| Satisfaction With Intervention | 2 months | number of participants who report being satisfied or very satisfied with the intervention at the two-month follow-up |
| Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 2 months | Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women. |
| Exploratory: HIV Viral Load | 2 months | Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS) |
| Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 6 months | Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women. |
| Exploratory: Alcohol Use- Number of Drinking Days | 6 months | Number of drinking days in the past 30 days (self-report) |
| Mid-point Survey Completion | 2 months | number of participants who complete the two-month survey |
Countries
South Africa
Participant flow
Recruitment details
Participants were recruited in the community between March 15, 2023 and Nov 11, 2023.
Pre-assignment details
People living with HIV who screened positive for heavy drinking were recruited with their primary romantic partners, who may or may not have been living with HIV and may or may not have screened positive for heavy drinking. 93 couples (186 individuals) were consented and randomized. Three couples (6 individuals) were found to be ineligible and thus were excluded from analyses of baseline characterisitcs, outcome measures and adverse events. Ninety couples (180 individuals) were included.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers People in this condition were living with HIV and screened positive for heavy drinking prior to enrollment. They received the standard of care for alcohol use in addition to a brief alcohol counseling session modeled after WHO guidelines and Dr. Conroy's intervention in Malawi, which uses participants' baseline AUDIT scores for messaging around alcohol reduction and lasts 5-10 minutes. They attended this brief counseling session with their primary romantic partner.
There were 31 people who were living with HIV and screened positive for heavy drinking assigned to this condition. | 31 |
| Enhanced Usual Care (EUC) Partners These participants were the primary romantic partners of the heavy drinkers assigned to the EUC arm. They attended the brief counseling session as a couple with the heavy drinker (their partner). | 31 |
| Motivational Interviewing (MI) - Heavy Drinkers People in this condition were living with HIV and screened positive for heavy drinking prior to enrollment. With their primary romantic partner, they were to attend three motivational interviewing sessions over a 60-day period. The sessions focused on communication between the couple, alcohol consumption patterns, and setting goals for alcohol-use reduction. | 30 |
| Motivational Interviewing (MI) - Partners These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. In addition to attending the motivational interviewing sessions as a couple with the heavy drinker (their partner), they received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
This group represents the romantic partners of the Heavy Drinkers assigned to the MI arm. 28 of these 30 participants also drank heavily. 15 were also living with HIV. | 30 |
| Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers People in this condition were living with HIV and screened positive for heavy drinking prior to enrollment. With their primary romantic partner, they attended three motivational interviewing sessions over a 60-day period. The sessions focused on communication between the couple, alcohol consumption patterns, and setting goals for alcohol-use reduction.
In addition to the counseling sessions, they received SMS messages twice per day prompting them to use a mobile app and a breathalyzer to test their blood alcohol levels (BAC). They received real-time feedback after each test. | 29 |
| Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners- Partner These participants were the primary romantic partners of the heavy drinkers assigned to the MI Plus arm. In addition to attending the motivational interviewing sessions with the heavy drinker (their partner), they recieved real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test. | 29 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Ineligible | 0 | 0 | 0 | 0 | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Enhanced Usual Care (EUC)- Heavy Drinkers | Enhanced Usual Care (EUC) Partners | Motivational Interviewing (MI) - Heavy Drinkers | Motivational Interviewing (MI) - Partners | Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers | Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners- Partner | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.65 years STANDARD_DEVIATION 6.69 | 38.39 years STANDARD_DEVIATION 6.83 | 37.47 years STANDARD_DEVIATION 7.51 | 35.73 years STANDARD_DEVIATION 5.59 | 39.07 years STANDARD_DEVIATION 6.42 | 36.62 years STANDARD_DEVIATION 6.82 | 37.66 years STANDARD_DEVIATION 6.68 |
| Number of participants who screened positive for heavy alcohol use | 31 Participants | 26 Participants | 30 Participants | 28 Participants | 29 Participants | 26 Participants | 170 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 31 Participants | 30 Participants | 29 Participants | 29 Participants | 28 Participants | 178 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment South Africa | 31 participants | 31 participants | 30 participants | 30 participants | 29 participants | 29 participants | 180 participants |
| Score on Alcohol Use Disorders Identification Test (AUDIT) | 14.13 units on a scale (0-28). STANDARD_DEVIATION 6.02 | 9.84 units on a scale (0-28). STANDARD_DEVIATION 6.67 | 14.63 units on a scale (0-28). STANDARD_DEVIATION 6.6 | 11.57 units on a scale (0-28). STANDARD_DEVIATION 6.04 | 15.38 units on a scale (0-28). STANDARD_DEVIATION 6.18 | 14.03 units on a scale (0-28). STANDARD_DEVIATION 6.9 | 13.2 units on a scale (0-28). STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 8 Participants | 23 Participants | 14 Participants | 16 Participants | 8 Participants | 21 Participants | 90 Participants |
| Sex: Female, Male Male | 23 Participants | 8 Participants | 16 Participants | 14 Participants | 21 Participants | 8 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 30 | 0 / 30 | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 30 | 0 / 30 | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 30 | 0 / 30 | 0 / 29 | 0 / 29 |
Outcome results
Primary
Enrollment Rate
Number of eligible individuals who enroll in the study
Time frame: Baseline (Time 0)
Population: All couples who were eligible after screening enrolled in the study (i.e., engaged in the informed consent process, completed the baseline questionnaire, and were randomized). No one refused participation after randomization either.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Enrollment Rate | 31 Participants |
| Enhanced Usual Care (EUC) - Partners | Enrollment Rate | 31 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Enrollment Rate | 30 Participants |
| Motivational Interviewing (MI)- Partners | Enrollment Rate | 30 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Enrollment Rate | 29 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Enrollment Rate | 29 Participants |
Primary
Retention Rate
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Retention Rate | 30 Participants |
| Enhanced Usual Care (EUC) - Partners | Retention Rate | 30 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Retention Rate | 29 Participants |
| Motivational Interviewing (MI)- Partners | Retention Rate | 29 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Retention Rate | 29 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Retention Rate | 29 Participants |
Secondary
70% Breathalyzer Completion
number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests
Time frame: 2 months
Population: Only participants in the MI Plus- Heavy Drinker arm were given the breathalyzers and prompted to take tests
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | 70% Breathalyzer Completion | 8 Participants |
Secondary
Exploratory: Alcohol Use- Number of Drinking Days
Number of drinking days in the past 30 days (self-report)
Time frame: 6 months
Population: This analysis excluded participants who did not complete the 6-month follow-up survey. Data is missing for one participant in the EUC- partner condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Exploratory: Alcohol Use- Number of Drinking Days | 8.2 days out of the last 30 | Standard Deviation 6.4 |
| Enhanced Usual Care (EUC) - Partners | Exploratory: Alcohol Use- Number of Drinking Days | 5.7 days out of the last 30 | Standard Deviation 6.3 |
| Motivational Interviewing (MI) - Heavy Drinkers | Exploratory: Alcohol Use- Number of Drinking Days | 6.3 days out of the last 30 | Standard Deviation 5.1 |
| Motivational Interviewing (MI)- Partners | Exploratory: Alcohol Use- Number of Drinking Days | 5.8 days out of the last 30 | Standard Deviation 5.6 |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Exploratory: Alcohol Use- Number of Drinking Days | 7.9 days out of the last 30 | Standard Deviation 5.5 |
| Motivational Interviewing Plus (MI Plus)- Partners | Exploratory: Alcohol Use- Number of Drinking Days | 8.0 days out of the last 30 | Standard Deviation 6.5 |
Secondary
Exploratory: Alcohol Use- Score on AUDIT at 2 Months
Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 12.0 units on a scale | Standard Deviation 6.2 |
| Enhanced Usual Care (EUC) - Partners | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 10.43 units on a scale | Standard Deviation 7.24 |
| Motivational Interviewing (MI) - Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 10.14 units on a scale | Standard Deviation 5.94 |
| Motivational Interviewing (MI)- Partners | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 11.11 units on a scale | Standard Deviation 5.62 |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 13.00 units on a scale | Standard Deviation 6.82 |
| Motivational Interviewing Plus (MI Plus)- Partners | Exploratory: Alcohol Use- Score on AUDIT at 2 Months | 11.38 units on a scale | Standard Deviation 6.62 |
Secondary
Exploratory: Alcohol Use- Score on AUDIT at 6 Months
Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 7.83 units on a scale | Standard Deviation 4.83 |
| Enhanced Usual Care (EUC) - Partners | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 9.93 units on a scale | Standard Deviation 6.41 |
| Motivational Interviewing (MI) - Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 8.80 units on a scale | Standard Deviation 6.77 |
| Motivational Interviewing (MI)- Partners | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 10.62 units on a scale | Standard Deviation 5.82 |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 8.27 units on a scale | Standard Deviation 5.81 |
| Motivational Interviewing Plus (MI Plus)- Partners | Exploratory: Alcohol Use- Score on AUDIT at 6 Months | 11.07 units on a scale | Standard Deviation 7.21 |
Secondary
Exploratory: ART Adherence
Percentage of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Time frame: 6 months
Population: This analysis includes participants who were living with HIV and completed the 6-month follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Exploratory: ART Adherence | 0.61 Percentage of pills taken | Standard Deviation 0.44 |
| Enhanced Usual Care (EUC) - Partners | Exploratory: ART Adherence | .91 Percentage of pills taken | Standard Deviation 0.19 |
| Motivational Interviewing (MI) - Heavy Drinkers | Exploratory: ART Adherence | 0.70 Percentage of pills taken | Standard Deviation 0.42 |
| Motivational Interviewing (MI)- Partners | Exploratory: ART Adherence | .92 Percentage of pills taken | Standard Deviation 0.23 |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Exploratory: ART Adherence | 0.58 Percentage of pills taken | Standard Deviation 0.45 |
| Motivational Interviewing Plus (MI Plus)- Partners | Exploratory: ART Adherence | .89 Percentage of pills taken | Standard Deviation 0.23 |
Secondary
Exploratory: HIV Viral Load
Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time frame: 2 months
Population: Viral load was only tested among heavy drinkers who completed the Time 2 follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Exploratory: HIV Viral Load | 26 Participants |
| Enhanced Usual Care (EUC) - Partners | Exploratory: HIV Viral Load | 28 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Exploratory: HIV Viral Load | 25 Participants |
Secondary
Final Survey Completion
number of couples who complete the six-month survey
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Final Survey Completion | 30 Participants |
| Enhanced Usual Care (EUC) - Partners | Final Survey Completion | 30 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Final Survey Completion | 29 Participants |
| Motivational Interviewing (MI)- Partners | Final Survey Completion | 29 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Final Survey Completion | 29 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Final Survey Completion | 29 Participants |
Secondary
Mid-point Survey Completion
number of participants who complete the two-month survey
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Mid-point Survey Completion | 30 Participants |
| Enhanced Usual Care (EUC) - Partners | Mid-point Survey Completion | 30 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Mid-point Survey Completion | 28 Participants |
| Motivational Interviewing (MI)- Partners | Mid-point Survey Completion | 28 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Mid-point Survey Completion | 29 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Mid-point Survey Completion | 29 Participants |
Secondary
Number of Participants Who Attended All Intervention Sessions
Number of participants who attend all three intervention sessions
Time frame: 2 months
Population: Participants in the Enhanced Usual Care Arm did were not assigned to any intervention sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Number of Participants Who Attended All Intervention Sessions | 0 Participants |
| Enhanced Usual Care (EUC) - Partners | Number of Participants Who Attended All Intervention Sessions | 0 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Number of Participants Who Attended All Intervention Sessions | 25 Participants |
| Motivational Interviewing (MI)- Partners | Number of Participants Who Attended All Intervention Sessions | 25 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Number of Participants Who Attended All Intervention Sessions | 26 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Number of Participants Who Attended All Intervention Sessions | 26 Participants |
Secondary
Satisfaction With Intervention
number of participants who report being satisfied or very satisfied with the intervention at the two-month follow-up
Time frame: 2 months
Population: We did not ask the participants in the Enhanced Usual Care arm about their satisfaction with the intervention. Two participants in the MI Heavy Drinkers and 2 participants in the MI Partners group did not complete the Time 2 survey, so were not asked these questions and not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care (EUC)- Heavy Drinkers | Satisfaction With Intervention | 0 Participants |
| Enhanced Usual Care (EUC) - Partners | Satisfaction With Intervention | 0 Participants |
| Motivational Interviewing (MI) - Heavy Drinkers | Satisfaction With Intervention | 28 Participants |
| Motivational Interviewing (MI)- Partners | Satisfaction With Intervention | 28 Participants |
| Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers | Satisfaction With Intervention | 28 Participants |
| Motivational Interviewing Plus (MI Plus)- Partners | Satisfaction With Intervention | 27 Participants |