Trial Outcomes & Findings for Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa (NCT NCT05756790)
NCT ID: NCT05756790
Last Updated: 2025-08-07
Results Overview
Number of eligible individuals who enroll in the study
COMPLETED
NA
186 participants
Baseline (Time 0)
2025-08-07
Participant Flow
Participants were recruited in the community between March 15, 2023 and Nov 11, 2023.
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.
Participant milestones
| Measure |
Enhanced Usual Care- 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.
|
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).
|
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 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.
|
Motivational Interviewing (MI) - Partners
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
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.
|
Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners
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 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
29
|
29
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Enhanced Usual Care- 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.
|
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).
|
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 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.
|
Motivational Interviewing (MI) - Partners
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
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.
|
Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners
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 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
0
|
2
|
2
|
Baseline Characteristics
Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care (EUC)- Heavy Drinkers
n=31 Participants
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.
|
Enhanced Usual Care (EUC) Partners
n=31 Participants
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).
|
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI) - Partners
n=30 Participants
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.
|
Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers
n=29 Participants
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.
|
Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners- Partner
n=29 Participants
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.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.65 years
STANDARD_DEVIATION 6.69 • n=5 Participants
|
38.39 years
STANDARD_DEVIATION 6.83 • n=7 Participants
|
37.47 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
35.73 years
STANDARD_DEVIATION 5.59 • n=4 Participants
|
39.07 years
STANDARD_DEVIATION 6.42 • n=21 Participants
|
36.62 years
STANDARD_DEVIATION 6.82 • n=8 Participants
|
37.66 years
STANDARD_DEVIATION 6.68 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
178 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
29 participants
n=21 Participants
|
29 participants
n=8 Participants
|
180 participants
n=8 Participants
|
|
Score on Alcohol Use Disorders Identification Test (AUDIT)
|
14.13 units on a scale (0-28).
STANDARD_DEVIATION 6.02 • n=5 Participants
|
9.84 units on a scale (0-28).
STANDARD_DEVIATION 6.67 • n=7 Participants
|
14.63 units on a scale (0-28).
STANDARD_DEVIATION 6.60 • n=5 Participants
|
11.57 units on a scale (0-28).
STANDARD_DEVIATION 6.04 • n=4 Participants
|
15.38 units on a scale (0-28).
STANDARD_DEVIATION 6.18 • n=21 Participants
|
14.03 units on a scale (0-28).
STANDARD_DEVIATION 6.90 • n=8 Participants
|
13.2 units on a scale (0-28).
STANDARD_DEVIATION 6.6 • n=8 Participants
|
|
Number of participants who screened positive for heavy alcohol use
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
170 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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.
Number of eligible individuals who enroll in the study
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=30 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=31 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=31 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Enrollment Rate
|
30 Participants
|
30 Participants
|
31 Participants
|
31 Participants
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of enrolled individuals who completed the final follow-up survey (6-months post baseline)
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=30 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=31 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=31 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Retention Rate
|
29 Participants
|
29 Participants
|
30 Participants
|
30 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 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.
number of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=28 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=28 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
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.
|
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Satisfaction With Intervention
|
28 Participants
|
28 Participants
|
0 Participants
|
0 Participants
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 2 monthsnumber of participants who complete the two-month survey
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=30 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=31 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=31 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Mid-point Survey Completion
|
28 Participants
|
28 Participants
|
30 Participants
|
30 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 monthsnumber of couples who complete the six-month survey
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=30 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=31 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=31 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Final Survey Completion
|
29 Participants
|
29 Participants
|
30 Participants
|
30 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Participants in the Enhanced Usual Care Arm did were not assigned to any intervention sessions.
Number of participants who attend all three intervention sessions
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=30 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=30 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
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.
|
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Attended All Intervention Sessions
|
25 Participants
|
25 Participants
|
0 Participants
|
0 Participants
|
26 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Only participants in the MI Plus- Heavy Drinker arm were given the breathalyzers and prompted to take tests
number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests
Outcome measures
| Measure |
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.
|
Motivational Interviewing (MI)- Partners
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=29 Participants
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.
|
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
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|---|---|---|---|---|---|---|
|
70% Breathalyzer Completion
|
—
|
—
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This analysis includes participants who were living with HIV and completed the 6-month follow-up survey.
Percentage of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=29 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=15 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=29 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=22 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=19 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
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|---|---|---|---|---|---|---|
|
Exploratory: ART Adherence
|
0.70 Percentage of pills taken
Standard Deviation 0.42
|
.92 Percentage of pills taken
Standard Deviation .23
|
0.61 Percentage of pills taken
Standard Deviation 0.44
|
.91 Percentage of pills taken
Standard Deviation .19
|
0.58 Percentage of pills taken
Standard Deviation 0.45
|
.89 Percentage of pills taken
Standard Deviation .23
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Number of drinking days in the past 30 days (self-report)
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=29 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=29 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=30 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=29 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Exploratory: Alcohol Use- Number of Drinking Days
|
6.3 days out of the last 30
Standard Deviation 5.1
|
5.8 days out of the last 30
Standard Deviation 5.6
|
8.2 days out of the last 30
Standard Deviation 6.4
|
5.7 days out of the last 30
Standard Deviation 6.3
|
7.9 days out of the last 30
Standard Deviation 5.5
|
8.0 days out of the last 30
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 2 monthsMean 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.
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=28 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=28 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=30 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=30 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Exploratory: Alcohol Use- Score on AUDIT at 2 Months
|
10.14 units on a scale
Standard Deviation 5.94
|
11.11 units on a scale
Standard Deviation 5.62
|
12.0 units on a scale
Standard Deviation 6.2
|
10.43 units on a scale
Standard Deviation 7.24
|
13.00 units on a scale
Standard Deviation 6.82
|
11.38 units on a scale
Standard Deviation 6.62
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Viral load was only tested among heavy drinkers who completed the Time 2 follow-up
Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=29 Participants
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.
|
Motivational Interviewing (MI)- Partners
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=30 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=29 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Exploratory: HIV Viral Load
|
25 Participants
|
—
|
26 Participants
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsMean 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.
Outcome measures
| Measure |
Motivational Interviewing (MI) - Heavy Drinkers
n=29 Participants
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.
|
Motivational Interviewing (MI)- Partners
n=29 Participants
These participants were the primary romantic partners of the heavy drinkers assigned to the MI arm. They attended the motivational interviewing sessions with the heavy drinker (their partner).
|
Enhanced Usual Care (EUC)- Heavy Drinkers
n=30 Participants
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.
|
Enhanced Usual Care (EUC) - Partners
n=30 Participants
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).
|
Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers
n=29 Participants
IPeople 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.
|
Motivational Interviewing Plus (MI Plus)- Partners
n=29 Participants
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 received real-time feedback about the drinker's BAC after each taken test and were alerted if the drinker missed a scheduled test.
|
|---|---|---|---|---|---|---|
|
Exploratory: Alcohol Use- Score on AUDIT at 6 Months
|
8.80 units on a scale
Standard Deviation 6.77
|
10.62 units on a scale
Standard Deviation 5.82
|
7.83 units on a scale
Standard Deviation 4.83
|
9.93 units on a scale
Standard Deviation 6.41
|
8.27 units on a scale
Standard Deviation 5.81
|
11.07 units on a scale
Standard Deviation 7.21
|
Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place