Alcohol Use, UnspecifiedEXTENDNCT03928418

Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda

A study testing In-person counseling session, Live phone call booster session and Technology (IVR or SMS) booster session in people with Alcohol Use, Unspecified and HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Use, Unspecified, HIV/AIDS
What is being tested?: In-person counseling session, Live phone call booster session and Technology (IVR or SMS) booster session
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: 1 siteUganda
Study dates: 19 Sep 2019to 30 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years and older;
HIV positive;
On ART for at least six months;
Reported alcohol use in the prior year at clinic entry;
Fluency in Runyakole;
Living within two hours travel time from the clinic;
Owning or having daily access to a cell phone;
Screening positive on the AUDIT-C

Who cannot join

Plans to move out of the catchment area within 6 months;
Unable to provide informed consent.
Participation in another research study.

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital
Mbarara

Other trials in Uganda

About this study

The EXTEND study is a randomized controlled trial to compare the uptake and acceptability, efficacy, and cost of methods of delivery of an alcohol intervention in reducing unhealthy alcohol use and increasing viral suppression among HIV positive persons in Uganda. The study arms are (a) in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim (b) in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and (c) standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

Read the detailed description

Alcohol consumption is a critical driver of HIV outcomes, especially in sub-Saharan Africa (SSA), where both are extremely common. Heavy alcohol use has been associated with reduced antiretroviral adherence, decreased HIV suppression, and increased mortality among those with HIV. Thus, reducing unhealthy alcohol use may improve HIV outcomes and is a high priority worldwide. Screening and brief counseling for alcohol use, especially multi-session approaches, have shown evidence for reducing alcohol use in resource rich settings and among persons with HIV. However, there are significant cost and human resource barriers to multiple session interventions in SSA, and it is not known whether alcohol interventions can improve HIV outcomes. Thus, the long-term goal of the EXTEND study is to develop and test interventions to reduce alcohol consumption and improve HIV outcomes, that can be feasibly integrated into routine HIV care in SSA.

Multi-session interventions that combine in-person visits with booster phone calls to reinforce the in-person counseling have shown good efficacy. Because cell phone use in Uganda is high, phone-based booster sessions conducted in-between the in-person sessions (that coincide with regularly scheduled clinic visits) may be feasible. However, phone-based booster sessions delivered by a live counselor ("live boosters") can be costly, time-consuming, limited to working hours, and dependent on good phone connections. Alternatively, automated cell phone-based booster sessions ("tech boosters"), can be conducted via interactive systems such as two-way Short Message Service (SMS, i.e. text messaging) or Interactive Voice Response (IVR) that allow for brief interactive sessions, with messages that are tailored to the participants' drinking goals and gender. Such automated tailored mobile phone-based interventions have been successful in improving several health behaviors in diverse populations. However, the uptake, acceptability, cost, and efficacy of live and tech booster calls for interventions for reducing alcohol use and improving HIV outcomes in SSA is not known. The investigators hypothesize that automated mobile phone-based technology can be leveraged as an efficacious way to implement multi-session alcohol interventions at a low burden and cost to both providers and patients in low resource settings.

Objectives

The EXTEND study is a randomized controlled trial (RCT) with a goal of estimating the uptake and acceptability, preliminary efficacy, and cost of methods of delivery of an intervention to reduce unhealthy drinking and HIV viral failure among persons in HIV care in rural Uganda (n=270). The RCT study arms are:

in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim;
in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and
standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

This study will be conducted in a large rural Ugandan HIV clinic. The end products of this study will be the preliminary comparisons of key outcomes to estimate effect sizes and inform the design of a future large-scale trial. The long-term aim is to implement interventions that reduce alcohol use and improve HIV outcomes feasibly and at low cost in low resource settings.

Conditions: Alcohol Use, Unspecified, HIV/AIDS
Being tested: In-person counseling session, Live phone call booster session, Technology (IVR or SMS) booster session
Medical subject headings: Alcohol Drinking, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

In-person counseling sessionBehavioural
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 sessionBehavioural
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 (IVR or SMS) booster sessionBehavioural
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.

Study groups in NCT03928418
Study group	Role	What they receive
Live Phone Call Booster Arm	Experimental	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. Receives: Behavioral: In-person counseling session; Behavioral: Live phone call booster session
Technology Booster Arm	Experimental	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. Receives: Behavioral: In-person counseling session; Behavioral: Technology (IVR or SMS) booster session
Standard of Care (SOC) Arm	No intervention	The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Alcohol Use Measured by Self Report
Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back
Measured: At 6 and 9 month visits (3 and 6 months post intervention).
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
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.
Measured: At 6 and 9 month visits (3 and 6 months post intervention).
Percentage of Participants With HIV Viral Suppression
Undetectable HIV viral load measured through plasma HIV viral load measurements.
Measured: At 9 month visit (6 months post intervention).

Secondary outcomes (9)

Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.
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.
Measured: At 6 and 9 month visits (3 and 6 months post-intervention)
Number of Heavy Drinking Days in the Prior 21 Days
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.
Measured: At 6 and 9 month visits (3 and 6 months post intervention).
Cluster of Differentiation-4 (CD4) Cell Count
CD4 cell count of participants measured through plasma CD4 measurements.
Measured: At nine months (6 months post intervention).
Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.
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.
Measured: At 6 and 9 month visits (3 and 6 months post intervention).
Booster Uptake - Completion
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.
Measured: 3 months
Booster Uptake - Counselor Call-back Requests
Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session.
Measured: 3 months
Booster Satisfaction - Client Satisfaction Scale-8
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.
Measured: At 6 month visit (3 months post intervention)
Booster Satisfaction - Usability
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.
Measured: At 6 month visit (3 months post intervention).
IVR Chosen as Technology Booster Mode
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201930 Aug 2021

First posted26 Apr 2019
Study start19 Sep 2019
Primary completion30 Aug 2021
Study completion30 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to 1 of 3 arms. After the trial, participants in the standard of care arm, will be offered the intervention.
Masking: Single blind
Who is masked: Investigator
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03928418
Sponsor's protocol ID: R01AA024990
Other IDs: U01AA024990
Acronym: EXTEND
Status last verified: Sep 2023
First submitted: 10 Apr 2019
Last updated: 14 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators will make the final de-identified dataset from this study readily available for research purposes to other individuals in the scientific community. Data will be shared with the scientific community at large by posters and presentations at local, national, and international scientific meetings, as well as via peer- reviewed publications.

Publications

Hahn JA, Woolf-King SE, Muyindike W. Adding fuel to the fire: alcohol's effect on the HIV epidemic in Sub-Saharan Africa. Curr HIV/AIDS Rep. 2011 Sep;8(3):172-80. doi: 10.1007/s11904-011-0088-2.
PubMed 21713433
Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
PubMed 23432593
Jonas DE, Garbutt JC, Amick HR, Brown JM, Brownley KA, Council CL, Viera AJ, Wilkins TM, Schwartz CJ, Richmond EM, Yeatts J, Evans TS, Wood SD, Harris RP. Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2012 Nov 6;157(9):645-54. doi: 10.7326/0003-4819-157-9-201211060-00544.
PubMed 23007881
Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.
PubMed 24505411
Crawford J, Larsen-Cooper E, Jezman Z, Cunningham SC, Bancroft E. SMS versus voice messaging to deliver MNCH communication in rural Malawi: assessment of delivery success and user experience. Glob Health Sci Pract. 2014 Jan 28;2(1):35-46. doi: 10.9745/GHSP-D-13-00155. eCollection 2014 Feb.
PubMed 25276561
Gichane MW, Camlin CS, Getahun M, Emenyonu N, Woolf-King S, Sanyu N, Katusiime A, Fatch R, Muyindike W, Hahn JA. Understanding Patients' Experiences with a Brief Alcohol Reduction Intervention among People Living with HIV in Uganda: A Qualitative Study. Subst Use Misuse. 2023;58(13):1714-1721. doi: 10.1080/10826084.2023.2244066. Epub 2023 Aug 8.
PubMed 37551890
Hahn JA, Fatch R, Emenyonu NI, Sanyu N, Katusiime A, Levine B, John Boscardin W, Chander G, Hutton H, Camlin CS, Woolf-King SE, Muyindike WR. Effect of two counseling interventions on self-reported alcohol consumption, alcohol biomarker phosphatidylethanol (PEth), and viral suppression among persons living with HIV (PWH) with unhealthy alcohol use in Uganda: A randomized controlled trial. Drug Alcohol Depend. 2023 Mar 1;244:109783. doi: 10.1016/j.drugalcdep.2023.109783. Epub 2023 Jan 21.
PubMed 36706675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
ClinicalTrials.gov ID: NCT03928418
Acronym / sponsor ID: EXTEND / R01AA024990
Conditions: Alcohol Use, Unspecified, HIV/AIDS
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Mbarara University of Science and Technology, Syracuse University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 19 Sep 2019 (actual)
Primary completion: 30 Aug 2021 (actual)
Study completion: 30 Aug 2021 (actual)
First posted: 26 Apr 2019 (actual)
Results: Posted 14 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives

in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim;
in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and
standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
Model description: Participants will be randomized to 1 of 3 arms. After the trial, participants in the standard of care arm, will be offered the intervention.

Arm	Type	Receives
Live Phone Call Booster Arm	Experimental	Behavioral: In-person counseling session, Behavioral: Live phone call booster sessionThe 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.
Technology Booster Arm	Experimental	Behavioral: In-person counseling session, Behavioral: Technology (IVR or SMS) booster sessionThe 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.
Standard of Care (SOC) Arm	No intervention	–The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 years and older;
HIV positive;
On ART for at least six months;
Reported alcohol use in the prior year at clinic entry;
Fluency in Runyakole;

Key exclusion criteria (3 listed)

Plans to move out of the catchment area within 6 months;
Unable to provide informed consent.
Participation in another research study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
In-person counseling sessionBrief 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.	Behavioural	Live Phone Call Booster Arm, Technology Booster Arm
Live phone call booster sessionBrief 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.	Behavioural	Live Phone Call Booster Arm
Technology (IVR or SMS) booster sessionBrief 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.	Behavioural	Technology Booster Arm

Primary outcome

Change in Alcohol Use Measured by Self Report
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
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.
Percentage of Participants With HIV Viral Suppression
Time frame: At 9 month visit (6 months post intervention).
Undetectable HIV viral load measured through plasma HIV viral load measurements.

9 secondary outcomes

Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.
Time frame: At 6 and 9 month visits (3 and 6 months post-intervention)
Number of Heavy Drinking Days in the Prior 21 Days
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Cluster of Differentiation-4 (CD4) Cell Count
Time frame: At nine months (6 months post intervention).
Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Booster Uptake - Completion
Time frame: 3 months
Booster Uptake - Counselor Call-back Requests
Time frame: 3 months
Booster Satisfaction - Client Satisfaction Scale-8
Time frame: At 6 month visit (3 months post intervention)
Booster Satisfaction - Usability
Time frame: At 6 month visit (3 months post intervention).
IVR Chosen as Technology Booster Mode
Time frame: 3 months

Results and safety

Results posted to the registry on 14 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Live Phone Call Booster Arm	91	85
Technology Booster Arm	91	87
Standard of Care (SOC) Arm	90	84

Primary outcome: Change in Alcohol Use Measured by Self Report

Time frame: At 6 and 9 month visits (3 and 6 months post intervention).. Mean (95% Confidence Interval). Unit: drinking days

Measure	Live Phone Call Booster Arm n = 85	Technology Booster Arm n = 87	Standard of Care (SOC) Arm n = 85
At 6 month visit	2.9 (2.6 to 3.3)	3.0 (2.6 to 3.4)	5.5 (5.0 to 6.1)
At 9 month visit	2.2 (1.9 to 2.5)	2.8 (2.4 to 3.1)	5.5 (5.0 to 6.0)

Live Phone Call Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): 3.5 (95% CI 2.1 to 4.9), p <0.001, Mixed Models Analysis
Technology Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): 3.6 (95% CI 2.2 to 5.1), p <0.001, Mixed Models Analysis

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

Primary outcome: Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)

Time frame: At 6 and 9 month visits (3 and 6 months post intervention).. Mean (95% Confidence Interval). Unit: ng/mL

Measure	Live Phone Call Booster Arm n = 85	Technology Booster Arm n = 87	Standard of Care (SOC) Arm n = 84
At 6 month visit	376.9 (259.6 to 494.1)	506.2 (386.1 to 626.3)	396.9 (290.5 to 503.4)
At 9 month visit	313.8 (220.3 to 407.4)	500.8 (340.2 to 661.3)	396.2 (288.1 to 504.3)

Live Phone Call Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): 36.4 (95% CI -117.5 to 190.3), p = 0.643, Mixed Models Analysis
Technology Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): -30.9 (95% CI -194.8 to 132.9), p = 0.711, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Percentage of Participants With HIV Viral Suppression

Time frame: At 9 month visit (6 months post intervention).. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Live Phone Call Booster Arm n = 80	Technology Booster Arm n = 84	Standard of Care (SOC) Arm n = 84
Value	95.0 (87.7 to 98.6)	94.1 (86.7 to 98.0)	92.9 (85.1 to 97.3)

Live Phone Call Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): -2.3 (95% CI -9.3 to 4.7), p = 0.515, Regression, Logistic
Technology Booster Arm vs Standard of Care (SOC) Arm: Mean Difference (Net): -0.9 (95% CI -8.3 to 6.4), p = 0.801, Regression, Logistic

Population analysed: 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.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Live Phone Call Booster Arm	1 of 90 (1.1%)	0 of 90 (0%)	0 of 90
Technology Booster Arm	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Standard of Care (SOC) Arm	0 of 89 (0%)	0 of 89 (0%)	0 of 89

Limitations and caveats (from the sponsor): The study of the impact of the interventions on HIV viral suppression was limited, as non-suppression is low in Uganda and was not an eligibility criterion. Ability to prevent cross-contamination across study arms was limited but we felt the likelihood of this was low as the intervention occurred at a large clinic. Persons with severe alcohol use disorder were not excluded, potentially limiting findings. The single site and occurrence of a global pandemic limit the generalizability of findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21713433Hahn JA, Woolf-King SE, Muyindike W. Adding fuel to the fire: alcohol's effect on the HIV epidemic in Sub-Saharan Africa. Curr HIV/AIDS Rep. 2011 Sep;8(3):172-80. doi: 10.1007/s11904-011-0088-2.
Background: PubMed 23432593Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
Background: PubMed 23007881Jonas DE, Garbutt JC, Amick HR, Brown JM, Brownley KA, Council CL, Viera AJ, Wilkins TM, Schwartz CJ, Richmond EM, Yeatts J, Evans TS, Wood SD, Harris RP. Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2012 Nov 6;157(9):645-54. doi: 10.7326/0003-4819-157-9-201211060-00544.
Background: PubMed 24505411Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.
Background: PubMed 25276561Crawford J, Larsen-Cooper E, Jezman Z, Cunningham SC, Bancroft E. SMS versus voice messaging to deliver MNCH communication in rural Malawi: assessment of delivery success and user experience. Glob Health Sci Pract. 2014 Jan 28;2(1):35-46. doi: 10.9745/GHSP-D-13-00155. eCollection 2014 Feb.
Derived from this study: PubMed 37551890Gichane MW, Camlin CS, Getahun M, Emenyonu N, Woolf-King S, Sanyu N, Katusiime A, Fatch R, Muyindike W, Hahn JA. Understanding Patients' Experiences with a Brief Alcohol Reduction Intervention among People Living with HIV in Uganda: A Qualitative Study. Subst Use Misuse. 2023;58(13):1714-1721. doi: 10.1080/10826084.2023.2244066. Epub 2023 Aug 8.
Derived from this study: PubMed 36706675Hahn JA, Fatch R, Emenyonu NI, Sanyu N, Katusiime A, Levine B, John Boscardin W, Chander G, Hutton H, Camlin CS, Woolf-King SE, Muyindike WR. Effect of two counseling interventions on self-reported alcohol consumption, alcohol biomarker phosphatidylethanol (PEth), and viral suppression among persons living with HIV (PWH) with unhealthy alcohol use in Uganda: A randomized controlled trial. Drug Alcohol Depend. 2023 Mar 1;244:109783. doi: 10.1016/j.drugalcdep.2023.109783. Epub 2023 Jan 21.
Individual participant dataSharing planned: Yes. The investigators will make the final de-identified dataset from this study readily available for research purposes to other individuals in the scientific community. Data will be shared with the scientific community at large by posters and presentations at local, national, and international scientific meetings, as well as via peer- reviewed publications.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith A Hahn, PhD, MA principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alcohol Use Measured by Self Report (time frame: At 6 and 9 month visits (3 and 6 months post intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03928418, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.