NCT02729337

Affecting the Epidemiology of HIV in Uganda

Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Center for Innovative Public Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 22 Years
• Healthy volunteers: Accepted

Summary

The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Detailed description

The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model of HIV Preventive Behavior. Intervention development will be iterative: In Phase 1, the investigators will identify an intervention content "map." Then, online focus groups (FG) will be conduct online with Ugandan young adults (n = 40-80) to confirm program components (e.g., social support via Text Buddy, optimal time of delivery of daily text messages) and saliency of intended program topics. In Phase 2, the investigation team will "translate" content into a bank of text messages that will be reviewed for comprehensiveness and inclusion of the most pertinent topics. The final pool of messages among Ugandan young adults will be tested in the Content Advisory Council (CAC; n = 30) to assess their reactions to the content, scope, style, and tone of the messages. In Phase 3, the investigators will merge the content with the software program developed to deliver the intervention and then internally conduct a functionality test of the programmed messages. Following, the protocol and program will be tested in a beta test of 20 Ugandan adults. In Phase 4, the investigators will test the intervention in a randomized controlled trial of 200 Ugandan young adults randomly assigned to either the intervention (n = 100) or control (n = 100) arms. The main outcome measures will focus on feasibility (e.g., recruitment and retention rates) and acceptability (e.g., Text Buddy). The primary efficacy outcome measures, measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b) sustained sexual abstinence, and (c) increased HIV testing rates. Specific Aims are as follows: Specific Aim 1: Design a 6-week text messaging-based HIV prevention and healthy sexuality program for adolescents 18-22 years old. Specific Aim 2: Pilot test the intervention for feasibility and acceptability among 18- to 22-year-old Ugandans. Specific Aim 3: Obtain preliminary data needed for a larger-scale controlled trial services study to examine program efficacy.

Conditions

• Sexual Abstinence
• HIV
• Contraceptive Usage

Interventions

Type	Name	Description
BEHAVIORAL	ITG (In This Together)	Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Timeline

• Start date: 2017-12-06
• Primary completion: 2019-01-18
• Completion: 2019-01-18
• First posted: 2016-04-06
• Last updated: 2020-02-18

Locations

1 site across 1 country: Uganda