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

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ClinicalTrials.gov Identifier: NCT03928418
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Syracuse University
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Alcohol Use, Unspecified HIV/AIDS Behavioral: In-person counseling session Behavioral: Live phone call booster session Behavioral: Technology (IVR or SMS) booster session Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Masking Description: The Research Assistant, who will collect study data including the study questionnaire and biological specimens for testing, will be blinded to the participants' study arm assignment.
Primary Purpose: Treatment
Official Title: Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

No Intervention: Standard of Care (SOC) Arm
The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).



Primary Outcome Measures :
  1. Efficacy Analyses - Change in alcohol use measured by self report (Time Line Follow Back ) [ Time Frame: At six and nine months (3 and 6 months post intervention). ]
    The primary outcome variable will be the number of days drinking (prior 3 weeks, TLFB).

  2. Efficacy Analyses - Change in alcohol use measured by the alcohol biomarker, Phosphatidylethanol (PEth) [ Time Frame: At six and nine months (3 and 6 months post intervention). ]
    The investigators will use PEth level as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.

  3. Efficacy Analyses - HIV viral suppression [ Time Frame: At nine months (6 months post intervention). ]
    Participants with undetectable HIV viral load measured through plasma HIV viral load measurements.


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score [ Time Frame: At nine months (6 months post intervention)hazardous drinking. ]
    AUDIT-C score in the prior 3 months being negative. AUDIT-C is a brief 3- item alcohol use screening questionnaire developed by the World Health Organization (WHO) and is scored on a scale of 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 and optimal for identifying

  2. Number of heavy drinking days [ Time Frame: At nine months (6 months post intervention). ]
    The number of heavy drinking days will be defined as ≥4/≥5 drinks per occasion by females/males, respectively.

  3. Cluster of Differentiation-4 (CD4) Cell Count [ Time Frame: At nine months (6 months post intervention). ]
    CD4 cell count of participants measured through plasma CD4 measurements.

  4. Antiretroviral therapy (ART) adherence [ Time Frame: At nine months (6 months post intervention). ]
    ART adherence as measured via self- report.

  5. Booster uptake: Client Satisfaction Scale-8 (CSQ-8) [ Time Frame: At nine months (6 months post intervention). ]
    Uptake will be the proportion of sessions in which the participant answered all the questions prior to the final sign-off message; the denominator for this will be the number of tech booster sessions initiated by the system. Live booster call uptake will be tabulated from the counselor's call record forms that will be entered weekly into the study database. The investigators will also determine the proportion of participants who request a counselor call back.

  6. Booster satisfaction [ Time Frame: At nine months (6 months post intervention).. ]
    The investigators will calculate intervention satisfaction in each arm using the Client Satisfaction Scale-8 (CSQ-8). Among those in the tech booster arm (Arm 2), the investigators will calculate usability via the System Usability Scale, used to evaluate new technology,146,147 and the proportions that chose SMS over IVR, overall and by reading literacy (yes/no). The CSQ-8 is a 8-item questionnaire with response options including 1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, and 4. Very satisfied, used to assess satisfaction with services in health and human services. The response options range from very negative to very positive correlating with low to high satisfaction. A linear transformation of scores is obtained by multiplying individual scores from each question by 3.125 to get a distribution between 25-100 and higher numbers are indicative of higher satisfaction.

  7. Booster uptake and satisfaction by assessing usability: System Usability Scale [ Time Frame: At nine months (6 months post intervention). ]
    Among those in the tech booster arm (Arm 2), the investigators will calculate usability via the System Usability Scale, used to evaluate new technology, and the proportions that chose SMS over IVR, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire with 5 response options from Strongly agree to strongly disagree. Participant's scores are converted to a number (0-40) and multiplied by 2.5 to get to a final score of (0-100). A score above 68 is considered above average and below 68 is considered below average. However, interpretations of scores involves normalizing of the scores to produce a percentile ranking.


Other Outcome Measures:
  1. Cost methodology [ Time Frame: At baseline and three months. ]
    To determine costs, the investigators will collect 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 and control groups (Table 4). Costs will be 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928418


Contacts
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Contact: Nneka I Emenyonu, DrPH 415 476 5806 Nneka.emenyonu@ucsf.edu
Contact: Judith Hahn judy.hahn@ucsf.edu

Locations
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Uganda
Mbarara University of Science and Technology/Mbarara Regional Referral Hospital Not yet recruiting
Mbarara, Uganda
Contact: Winnie Muyindike, MBChB, MMED    +256 772 521619    wmuyindike@gmail.com   
Principal Investigator: Winnie R Muyindike, MBChB, MMED         
Sponsors and Collaborators
University of California, San Francisco
Mbarara University of Science and Technology
Syracuse University
Investigators
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Principal Investigator: Judith A Hahn, PhD, MA University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03928418     History of Changes
Other Study ID Numbers: R01AA024990 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After the RCT is concluded and data analyses are completed by the study team.
Access Criteria: The data and associated documentation will be made available to users only under a data-sharing agreement with the study investigators that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. User registration is required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release of data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No