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

NCT ID: NCT03928418

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2021-08-30

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.

Conditions

Alcohol Use, Unspecified; HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

In-person counseling session

Intervention Type: 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 session

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

In-person counseling session

Intervention Type: 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.

Technology (IVR or SMS) booster session

Intervention Type: 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.

Standard of Care (SOC) Arm

The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mbarara University of Science and Technology

OTHER

Sponsor Role: collaborator

Syracuse University

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith A Hahn, PhD, MA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital

Mbarara, , Uganda

Countries

Uganda

References

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.

Reference Type: BACKGROUND

PMID: 21713433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23432593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23007881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24505411 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25276561 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37551890 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36706675 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

U01AA024990

Identifier Type: NIH

Identifier Source: secondary_id

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R01AA024990

Identifier Type: NIH

Identifier Source: org_study_id

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