Affecting the Epidemiology of HIV in Uganda
1 other identifier
interventional
203
1 country
1
Brief Summary
The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedStudy Start
First participant enrolled
December 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2019
CompletedFebruary 18, 2020
February 1, 2020
1.1 years
March 15, 2016
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Program feasibility: Recruitment
The number of participants recruited for the RCT (n=200)
24 weeks
Program feasibility: Retention
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
Participant ratings of program features (e.g., Text Buddy) at intervention end
At intervention end, 6-weeks post baseline
Secondary Outcomes (3)
Percent of participants reporting condom use during sex as assessed by self-report
At intervention end, 6-weeks post baseline
Percent of participants reporting abstinence as assessed by self-report
At intervention end, 6-weeks post baseline
Percent of participants who have gotten an HIV test as assessed by self-report
At intervention end, 6-weeks post baseline
Study Arms (2)
ITG (In This Together)
EXPERIMENTALThis 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.
Control Group
NO INTERVENTIONGiven 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.
Interventions
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Internet Solutions for Kids Uganda
Mbarara, Uganda
Related Publications (1)
Ybarra ML, Agaba E, Nyemara N. A Pilot RCT Evaluating InThistoGether, an mHealth HIV Prevention Program for Ugandan Youth. AIDS Behav. 2021 Oct;25(10):3437-3448. doi: 10.1007/s10461-021-03237-5. Epub 2021 May 7.
PMID: 33963477DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Ybarra, MPH PHD
Center for Innovative Public Health Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
April 6, 2016
Study Start
December 6, 2017
Primary Completion
January 18, 2019
Study Completion
January 18, 2019
Last Updated
February 18, 2020
Record last verified: 2020-02