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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

186 participants

Primary outcome timeframe

Baseline (Time 0)

Results posted on

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

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

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

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

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 months

Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)

Outcome measures

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 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.

number of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up

Outcome measures

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 months

number of participants who complete the two-month survey

Outcome measures

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 months

number of couples who complete the six-month survey

Outcome measures

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 months

Population: 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

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 months

Population: 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

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.
70% Breathalyzer Completion
8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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

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.
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 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.

Number of drinking days in the past 30 days (self-report)

Outcome measures

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 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.

Outcome measures

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 months

Population: 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

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced Usual Care (EUC) - Partners

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Motivational Interviewing (MI) - Heavy Drinkers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Motivational Interviewing (MI) - Partners

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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: 303-522-9439

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place