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

Not Applicable

Completed

• Conditions: Alcohol Use, Unspecified; HIV/AIDS
• Interventions: Behavioral: In-person counseling session; Behavioral: Technology (IVR or SMS) booster session; Behavioral: Live phone call booster session

• Registration Number: NCT03928418
• Lead Sponsor: University of California, San Francisco

Brief Summary

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).

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:

1. in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim;

2. in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and

3. 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.

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Study Start: 2019-09-19
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Results First Submitted: 2023-04-20
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Results First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology Booster Arm	In-person counseling session	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.
Technology Booster Arm	Technology (IVR or SMS) booster session	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.
Live Phone Call Booster Arm	In-person counseling session	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.
Live Phone Call Booster Arm	Live phone call booster session	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.

Primary Outcome Measures

Name	Time	Method
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)	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.
Change in Alcohol Use Measured by Self Report	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
Percentage of Participants With HIV Viral Suppression	At 9 month visit (6 months post intervention).	Undetectable HIV viral load measured through plasma HIV viral load measurements.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda