Affecting the Epidemiology of HIV in Uganda

February 14, 2020 updated by: Center for Innovative Public Health Research

Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbarara, Uganda
        • Internet Solutions for Kids Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: ITG (In This Together)
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program feasibility: Recruitment
Time Frame: 24 weeks
The number of participants recruited for the RCT (n=200)
24 weeks
Program feasibility: Retention
Time Frame: Through study completion, an average of 6 weeks
The number of participants that will remain in the study at program end (80%)
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
Participant ratings of program features (e.g., Text Buddy) at intervention end
At intervention end, 6-weeks post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of participants reporting condom use during sex as assessed by self-report
Time Frame: 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
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
The percent of participants who report, at intervention end, not having sex versus having sex at least once, during the intervention period
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
The percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period
At intervention end, 6-weeks post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Innovative Public Health Research

Collaborators

Internet Solutions for Kids Uganda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2017

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MH109296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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