Clinical trial NCT03928418: Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Official title: Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
HIV/AIDS
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
name: Syracuse University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-04-26
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Alcohol Use Measured by Self Report
timeFrame: At 6 and 9 month visits (3 and 6 months post intervention).
measure: Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
timeFrame: At 6 and 9 month visits (3 and 6 months post intervention).
measure: Percentage of Participants With HIV Viral Suppression
timeFrame: At 9 month visit (6 months post intervention).
Secondary outcomes:
measure: Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.
timeFrame: At 6 and 9 month visits (3 and 6 months post-intervention)
measure: Number of Heavy Drinking Days in the Prior 21 Days
timeFrame: At 6 and 9 month visits (3 and 6 months post intervention).
measure: Cluster of Differentiation-4 (CD4) Cell Count
timeFrame: At nine months (6 months post intervention).
measure: Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.
timeFrame: At 6 and 9 month visits (3 and 6 months post intervention).
measure: Booster Uptake - Completion
timeFrame: 3 months
measure: Booster Uptake - Counselor Call-back Requests
timeFrame: 3 months
measure: Booster Satisfaction - Client Satisfaction Scale-8
timeFrame: At 6 month visit (3 months post intervention)
measure: Booster Satisfaction - Usability
timeFrame: At 6 month visit (3 months post intervention).
measure: IVR Chosen as Technology Booster Mode
timeFrame: 3 months
Other outcomes:
measure: Cost Methodology
timeFrame: Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months.
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology/Mbarara Regional Referral Hospital
Study officials:
affiliation: University of California, San Francisco
name: Judith A Hahn, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.