Trial Outcomes & Findings for Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda (NCT NCT03928418)

NCT ID: NCT03928418

Last Updated: 2023-09-14

Results Overview

Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 272 participants
• Primary outcome timeframe: At 6 and 9 month visits (3 and 6 months post intervention).
• Results posted on: 2023-09-14

Participant Flow

Study recruitment occurred from September 2019 through December 2020. 997 persons were screened; 272 unique individuals were enrolled and randomized. The first 3 people were enrolled as pilot participants and are excluded from all analyses, leaving 269 total persons for analysis.

The first 3 individuals enrolled in the study were considered "pilot" participants. They were randomized to one of the three study arms separately from the randomization for the main study participants. They are excluded from all analyses.

Participant milestones

Measure	Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Overall Study STARTED	91	91	90
Overall Study Pilot Participant	1	1	1
Overall Study 6-month Visit	83	86	85
Overall Study COMPLETED	85	87	84
Overall Study NOT COMPLETED	6	4	6

Reasons for withdrawal

Measure	Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Overall Study Lost to Follow-up	5	3	5
Overall Study Pilot participant - excluded from analyses	1	1	1

Baseline Characteristics

n=1 SOC participant missing age

Baseline characteristics by cohort

Measure	Live Phone Call Booster Arm n=90 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=90 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=89 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).	Total n=269 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=90 Participants • n=1 SOC participant missing age	0 Participants n=90 Participants • n=1 SOC participant missing age	0 Participants n=88 Participants • n=1 SOC participant missing age	0 Participants n=268 Participants • n=1 SOC participant missing age
Age, Categorical Between 18 and 65 years	89 Participants n=90 Participants • n=1 SOC participant missing age	90 Participants n=90 Participants • n=1 SOC participant missing age	85 Participants n=88 Participants • n=1 SOC participant missing age	264 Participants n=268 Participants • n=1 SOC participant missing age
Age, Categorical >=65 years	1 Participants n=90 Participants • n=1 SOC participant missing age	0 Participants n=90 Participants • n=1 SOC participant missing age	3 Participants n=88 Participants • n=1 SOC participant missing age	4 Participants n=268 Participants • n=1 SOC participant missing age
Age, Continuous	40.0 years n=90 Participants • n = 1 SOC participant missing age.	39.5 years n=90 Participants • n = 1 SOC participant missing age.	38.5 years n=88 Participants • n = 1 SOC participant missing age.	39.5 years n=268 Participants • n = 1 SOC participant missing age.
Sex: Female, Male Female	33 Participants n=90 Participants	30 Participants n=90 Participants	30 Participants n=89 Participants	93 Participants n=269 Participants
Sex: Female, Male Male	57 Participants n=90 Participants	60 Participants n=90 Participants	59 Participants n=89 Participants	176 Participants n=269 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Uganda	90 participants n=90 Participants	90 participants n=90 Participants	89 participants n=89 Participants	269 participants n=269 Participants

PRIMARY outcome

Timeframe: At 6 and 9 month visits (3 and 6 months post intervention).

Population: The overall number of participants analyzed is the number of participants with self-reported alcohol use data at 6 months or 9 months.

Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back

Outcome measures

Measure	Live Phone Call Booster Arm n=85 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=87 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=85 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Change in Alcohol Use Measured by Self Report At 6 month visit	2.9 drinking days Interval 2.6 to 3.3	3.0 drinking days Interval 2.6 to 3.4	5.5 drinking days Interval 5.0 to 6.1
Change in Alcohol Use Measured by Self Report At 9 month visit	2.2 drinking days Interval 1.9 to 2.5	2.8 drinking days Interval 2.4 to 3.1	5.5 drinking days Interval 5.0 to 6.0

PRIMARY outcome

Timeframe: At 6 and 9 month visits (3 and 6 months post intervention).

Population: The overall number of participants analyzed is the number of participants with PEth alcohol biomarker data at 6 months or 9 months. n = 1 SOC participant was missing PEth from their 6 month visit.

Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.

Outcome measures

Measure	Live Phone Call Booster Arm n=85 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=87 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=84 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) At 6 month visit	376.9 ng/mL Interval 259.6 to 494.1	506.2 ng/mL Interval 386.1 to 626.3	396.9 ng/mL Interval 290.5 to 503.4
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) At 9 month visit	313.8 ng/mL Interval 220.3 to 407.4	500.8 ng/mL Interval 340.2 to 661.3	396.2 ng/mL Interval 288.1 to 504.3

PRIMARY outcome

Timeframe: At 9 month visit (6 months post intervention).

Population: n = 5 participants in the live phone call booster arm and n = 3 participants in the technology booster arm were missing viral load results at their 9 month visits and are excluded from this analysis.

Undetectable HIV viral load measured through plasma HIV viral load measurements.

Outcome measures

Measure	Live Phone Call Booster Arm n=80 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=84 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=84 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Percentage of Participants With HIV Viral Suppression	95.0 percentage of participants Interval 87.7 to 98.6	94.1 percentage of participants Interval 86.7 to 98.0	92.9 percentage of participants Interval 85.1 to 97.3

SECONDARY outcome

Timeframe: At 6 and 9 month visits (3 and 6 months post-intervention)

Population: Participants included are those with AUDIT-C data available at the 6- and 9-month visits.

Unhealthy alcohol use via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), in the prior 3 months. The AUDIT-C ranges from 0-12. A score of 0 reflects no alcohol use; a score of 3 or higher in adult women or 4 or higher in men is considered positive for unhealthy alcohol use.

Outcome measures

Measure	Live Phone Call Booster Arm n=85 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=87 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=84 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. At 6 month visit	43.4 percentage of participants Interval 32.5 to 54.7	46.5 percentage of participants Interval 35.7 to 57.6	66.7 percentage of participants Interval 55.5 to 76.6
Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. At 9 month visit	32.9 percentage of participants Interval 23.1 to 44.0	40.2 percentage of participants Interval 29.9 to 51.3	69.0 percentage of participants Interval 58.0 to 78.7

SECONDARY outcome

Timeframe: At 6 and 9 month visits (3 and 6 months post intervention).

Population: At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85). At 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).

The number of heavy drinking days in the prior 21 days will be defined as the number of days from the alcohol use timeline follow-back with ≥4/≥5 drinks reported by females/males, respectively, in the prior 21 days.

Outcome measures

Measure	Live Phone Call Booster Arm n=85 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=87 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=85 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Number of Heavy Drinking Days in the Prior 21 Days At 6 month visit	1.2 days Interval 1.0 to 1.5	1.4 days Interval 1.1 to 1.7	3.6 days Interval 3.2 to 4.0
Number of Heavy Drinking Days in the Prior 21 Days At 9 month visit	0.6 days Interval 0.5 to 0.8	1.5 days Interval 1.3 to 1.8	3.3 days Interval 2.9 to 3.7

SECONDARY outcome

Timeframe: At nine months (6 months post intervention).

Population: CD4 count data were not collected and as such, this analysis was not completed. We had intended to extract CD4 cell counts from HIV clinic records; however, the clinic discontinued CD4 testing when viral load monitoring became routine.

CD4 cell count of participants measured through plasma CD4 measurements.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 and 9 month visits (3 and 6 months post intervention).

Population: At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85). At 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).

Percent self-reported antiretroviral therapy (ART) adherence in the prior 30 days. This measure was defined as the lower of two self-reported measures of ART adherence in the prior 30 days: 1. a visual analog scale: a line ranging from 0% (no doses) to 100% (all doses) on which participants indicated how many of their ART doses they had taken, and 2. the percentage of days that the participant reported taking all of their ART pills.

Outcome measures

Measure	Live Phone Call Booster Arm n=85 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=87 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=85 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. At 6 month visit	92.3 adherence percentage Interval 89.4 to 95.2	91.6 adherence percentage Interval 88.4 to 94.7	90.4 adherence percentage Interval 88.2 to 92.7
Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. At 9 month visit	93.3 adherence percentage Interval 91.3 to 95.4	93.3 adherence percentage Interval 90.3 to 96.2	92.8 adherence percentage Interval 91.0 to 94.5

SECONDARY outcome

Timeframe: 3 months

Population: 0 participants from the SOC arm are included here because they did not receive boosters.

Technology booster uptake is defined as the percentage of technology booster sessions initiated by the system, in which the participant answered all the required questions.

Live booster call uptake is defined as the percentage of live booster calls attempted, that were completed by the participant.

This was a descriptive analysis of the mean percentage of boosters completed per participant.

Outcome measures

Measure	Live Phone Call Booster Arm n=290 Boosters attempted The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=2114 Boosters attempted The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Booster Uptake - Completion	86.5 % boosters completed Interval 81.8 to 91.3	44.7 % boosters completed Interval 33.4 to 51.1	—

SECONDARY outcome

Timeframe: 3 months

Population: This descriptive analysis was only completed among participants in the technology booster arm.

Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session.

Outcome measures

Measure	Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=90 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Booster Uptake - Counselor Call-back Requests	—	57 Participants	—

SECONDARY outcome

Timeframe: At 6 month visit (3 months post intervention)

Intervention satisfaction in each arm will be assessed using the Client Satisfaction Scale-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess satisfaction with services in health and human services. The response options (1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, 4. Very satisfied) range from very negative to very positive, correlating with low to high satisfaction. The scale ranges from 25-100, with higher numbers indicating higher satisfaction.

Outcome measures

Measure	Live Phone Call Booster Arm n=83 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=86 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=85 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Booster Satisfaction - Client Satisfaction Scale-8	93.3 score on scale Interval 91.9 to 94.8	93.1 score on scale Interval 91.8 to 94.5	90.0 score on scale Interval 88.2 to 91.8

SECONDARY outcome

Timeframe: At 6 month visit (3 months post intervention).

Population: System usability was assessed only within the technology booster arm.

Usability was assessed in the technology booster arm via the System Usability Scale (SUS), used to evaluate new technology, and the proportions that chose short message service (SMS, text message) over interactive voice recognition (IVR) as the mode of booster delivery, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire; raw score totals range from 0 to 40 with higher scores indicating better usability.

Outcome measures

Measure	Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=86 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Booster Satisfaction - Usability	—	34.9 score on scale Interval 34.2 to 35.5	—

SECONDARY outcome

Timeframe: 3 months

Population: Participants randomized to the technology booster arm, included in this descriptive analysis overall and stratified by literacy status.

Participants in the technology booster arm chose to receive the boosters via either interactive voice response (IVR) or short message service (SMS, text). We report here on the number of participants choosing IVR among technology booster arm participants overall, and by literacy status.

Outcome measures

Measure	Live Phone Call Booster Arm n=90 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=77 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=13 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
IVR Chosen as Technology Booster Mode	59 Participants	46 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months.

Population: The costing analysis was conducted for the study intervention booster session mode of delivery (ie. live call, interactive voice recognition (IVR) and short message service (SMS) technology boosters). Participants from the SOC arm who received the intervention after a wait-list control period are also included here.

To determine costs, the investigators collected data to capture all relevant direct (e.g. equipment) and indirect (e.g. administrative), fixed (or 'start-up') and variable (or 'recurring') costs related to the intervention activities. Costs were differentiated by intervention component (e.g. clinic-based counseling versus remote booster sessions) and by booster session mode of delivery (i.e. live booster versus tech booster, and between SMS and IVR tech boosters). Total observed costs (US$) were collected by booster session delivery mode and divided by the number of participants who received that booster session type. That includes participants who were randomized to each arm as well as participants randomized to the standard of care (SOC) arm who received the intervention after a wait-list control period. No individual-level data were collected; because of this, no measures of dispersion exist.

Outcome measures

Measure	Live Phone Call Booster Arm n=160 Participants The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=40 Participants The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=61 Participants The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Cost Methodology	144.27 cost (US$) per participant	312.79 cost (US$) per participant	315.45 cost (US$) per participant

Adverse Events

Live Phone Call Booster Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Technology Booster Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care (SOC) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Live Phone Call Booster Arm n=90 participants at risk The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.	Technology Booster Arm n=90 participants at risk The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.	Standard of Care (SOC) Arm n=89 participants at risk The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Psychiatric disorders Suicidal ideation	1.1% 1/90 • Number of events 1 • 9 months The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions. Adverse events were recorded during routine study visits when self reported by participants.	0.00% 0/90 • 9 months The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions. Adverse events were recorded during routine study visits when self reported by participants.	0.00% 0/89 • 9 months The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions. Adverse events were recorded during routine study visits when self reported by participants.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Judy Hahn

University of California San Francisco

Phone: 415-476-5815

Email: judy.hahn@ucsf.edu

Results disclosure agreements

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