Affecting the Epidemiology of HIV in Uganda

Not Applicable

Completed

• Conditions: Contraceptive Usage; Sexual Abstinence; HIV
• Interventions: Behavioral: ITG (In This Together)

• Registration Number: NCT02729337
• Lead Sponsor: Center for Innovative Public Health Research

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2017-12-06
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITG (In This Together)	ITG (In This Together)	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.

Primary Outcome Measures

Name	Time	Method
Program feasibility: Recruitment	24 weeks	The number of participants recruited for the RCT (n=200)
Program feasibility: Retention	Through study completion, an average of 6 weeks	The number of participants that will remain in the study at program end (80%)
Program acceptability as assessed by a scale created for the RCT	At intervention end, 6-weeks post baseline	Participant ratings of program features (e.g., Text Buddy) at intervention end

Secondary Outcome Measures

Name	Time	Method
Percent of participants reporting condom use during sex as assessed by self-report	At intervention end, 6-weeks post baseline	The percent of participants who report, at intervention end, using condoms during sex always versus not using condoms at least once, during the intervention period
Percent of participants reporting abstinence as assessed by self-report	At intervention end, 6-weeks post baseline	The percent of participants who report, at intervention end, not having sex versus having sex at least once, during the intervention period
Percent of participants who have gotten an HIV test as assessed by self-report	At intervention end, 6-weeks post baseline	The percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period

Trial Locations

Locations (1)

Internet Solutions for Kids Uganda; 🇺🇬 Mbarara, Uganda