N/A
Completed N=272
Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Alcohol Use, Unspecified · HIV
Source: ClinicalTrials.gov NCT03928418 ↗
Enrolled (actual)
272
Serious AEs
0.4%
Results posted
Sep 2023
Primary outcomePrimary: Change in Alcohol Use Measured by Self Report — 2.9; 3.0; 5.5; 2.2 drinking days — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alcohol Use Measured by Self Report |
2.9; 3.0; 5.5; 2.2; 2.8; 5.5 | <0.001 sig |
| PRIMARY Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) |
376.9; 506.2; 396.9; 313.8; 500.8; 396.2 | 0.643 |
| PRIMARY Percentage of Participants With HIV Viral Suppression |
95.0; 94.1; 92.9 | 0.515 |
| SECONDARY Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. |
43.4; 46.5; 66.7; 32.9; 40.2; 69.0 | <0.001 sig |
| SECONDARY Number of Heavy Drinking Days in the Prior 21 Days |
1.2; 1.4; 3.6; 0.6; 1.5; 3.3 | 0.002 sig |
| SECONDARY Cluster of Differentiation-4 (CD4) Cell Count |
— | — |
| SECONDARY Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. |
92.3; 91.6; 90.4; 93.3; 93.3; 92.8 | 0.610 |
| SECONDARY Booster Uptake - Completion |
86.5; 44.7 | — |
| SECONDARY Booster Uptake - Counselor Call-back Requests |
57 | — |
| SECONDARY Booster Satisfaction - Client Satisfaction Scale-8 |
93.3; 93.1; 90.0 | — |
| SECONDARY Booster Satisfaction - Usability |
34.9 | — |
| SECONDARY IVR Chosen as Technology Booster Mode |
59; 46; 13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03928418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.