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

NCT03928418 | Completed Results

• 2 other identifiers: R01AA024990U01AA024990
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use, Unspecified; HIV/AIDS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.

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

• Number of Heavy Drinking Days in the Prior 21 Days

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

• Cluster of Differentiation-4 (CD4) Cell Count

  At nine months (6 months post intervention).

• Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.

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

• Booster Uptake - Completion

  3 months

Other Outcomes (1)

• Cost Methodology

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

Study Arms (3)

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.

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.

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).

Interventions

In-person counseling session BEHAVIORAL

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 Arm; Technology Booster Arm

Live phone call booster session BEHAVIORAL

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.

Live Phone Call Booster Arm

Technology (IVR or SMS) booster session BEHAVIORAL

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.

Technology Booster Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mbarara University of Science and Technology: collaborator
• Syracuse University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Related Publications (7)

• 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.

  PMID: 21713433 BACKGROUND

• 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.

  PMID: 23432593 BACKGROUND

• 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.

  PMID: 23007881 BACKGROUND

• 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.

  PMID: 24505411 BACKGROUND

• 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.

  PMID: 25276561 BACKGROUND

• 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.

  PMID: 37551890 DERIVED

• 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.

  PMID: 36706675 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Acquired Immunodeficiency Syndrome

Interventions

Technology; Spermine Synthase

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Judy Hahn
• Organization: University of California San Francisco

judy.hahn@ucsf.edu

415-476-5815

Study Officials

• Judith A Hahn, PhD, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to 1 of 3 arms. After the trial, participants in the standard of care arm, will be offered the intervention.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 26, 2019
• Study Start: September 19, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

UG (1)