Overview

This trial is active, not recruiting.

Conditions sexual abstinence, hiv, contraceptive usage
Treatment itg (in this together)
Sponsor Center for Innovative Public Health Research
Collaborator Internet Solutions for Kids Uganda
Start date June 2015
End date June 2018
Trial size 200 participants
Trial identifier NCT02729337, MH109296

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
This will be a multi-week behavioral intervention delivered daily via text messaging. Content will be based upon the IMB model of HIV preventive behavior and informed by our formative work.
itg (in this together)
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
(No Intervention)
Given the preliminary nature of the intervention development, the control group will be inactive but blinded. They will receive two messages per week encouraging them to make healthy sexual decisions to reduce their HIV risk. Messages will be didactic and not driven by the IMB model.

Primary Outcomes

Measure
Program feasibility: Recruitment
time frame: 24 weeks
Program feasibility: Retention
time frame: Through study completion, an average of 6 weeks
Program acceptability as assessed by a scale created for the RCT
time frame: At intervention end, 6-weeks post baseline

Secondary Outcomes

Measure
Percent of participants reporting condom use during sex as assessed by self-report
time frame: At intervention end, 6-weeks post baseline
Percent of participants reporting abstinence as assessed by self-report
time frame: At intervention end, 6-weeks post baseline
Percent of participants who have gotten an HIV test as assessed by self-report
time frame: At intervention end, 6-weeks post baseline

Eligibility Criteria

Male or female participants from 18 years up to 22 years old.

Inclusion Criteria: - living in Uganda - aged 18-22 years - able to read English - exclusive owner of a cell phone - using text messaging for at least 6 months - intended to have the same phone number or the next six months - able to access the Internet (to complete online surveys) - able to provide informed consent Exclusion Criteria: - no other exclusion criteria will be applied

Additional Information

Official title Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
Principal investigator Michele Ybarra, MPH PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Center for Innovative Public Health Research.