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Affecting the Epidemiology of HIV in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729337
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Internet Solutions for Kids Uganda
Information provided by (Responsible Party):
Center for Innovative Public Health Research

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

Condition or disease Intervention/treatment Phase
Sexual Abstinence HIV Contraceptive Usage Behavioral: ITG (In This Together) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729337


Locations
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Uganda
Internet Solutions for Kids Uganda
Mbarara, Uganda
Sponsors and Collaborators
Center for Innovative Public Health Research
Internet Solutions for Kids Uganda
Investigators
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Principal Investigator: Michele Ybarra, MPH PHD Center for Innovative Public Health Research
  Study Documents (Full-Text)

Documents provided by Center for Innovative Public Health Research:
Informed Consent Form  [PDF] August 23, 2017

More Information
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Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT02729337    
Other Study ID Numbers: MH109296
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center for Innovative Public Health Research:
technology
adolescent
developing country
hiv prevention
mHealth