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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, Alcohol Use, Unspecified

Intervention / Treatment
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* Behavioral: In-person counseling session
* Behavioral: Live phone call booster session
* Behavioral: Technology (IVR or SMS) booster session


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live Phone Call Booster Arm<br>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. | Behavioral: In-person counseling session<br>* 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.<br>Behavioral: Live phone call booster session<br>* 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.<br>|
| Experimental: Technology Booster Arm<br>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. | Behavioral: In-person counseling session<br>* 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.<br>Behavioral: Technology (IVR or SMS) booster session<br>* 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.<br>|
| No Intervention: Standard of Care (SOC) Arm<br>The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | At 9 month visit (6 months post intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 months |