Skip to main content
OpenTrials
Completed

NCT Number: NCT02729337

Affecting the Epidemiology of HIV in Uganda

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sexual Abstinence Behavior Contraception Behavior Contraceptive Usage HIV Reproductive Behavior Sexual Behavior

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internet Solutions for Kids Uganda

Mbarara, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITG (In This Together)

Behavioral

Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Primary outcomes

  1. Program feasibility: Recruitment

    Time frame: 24 weeks

    The number of participants recruited for the RCT (n=200)

  2. 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%)

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Collaborators

  • Internet Solutions for Kids Uganda

Registry information

Official study title

Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2016
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.