Sexual AbstinenceNCT02729337
Affecting the Epidemiology of HIV in Uganda
A study testing ITG (In This Together) in people with Sexual Abstinence and HIV, run by Center for Innovative Public Health Research at 1 site in Uganda.
Trial summary
The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Abstinence, HIV, Contraceptive Usage
- What is being tested?
- ITG (In This Together)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUganda
- Study dates
- 6 Dec 2017to 18 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- no other exclusion criteria will be applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexual Abstinence, HIV, Contraceptive Usage
- Being tested
- ITG (In This Together)
- Keywords
- technology, adolescent, developing country, hiv prevention, mHealth
- Medical subject headings
- Sexual Abstinence, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITG (In This Together)Behavioural
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
| Study group | Role | What they receive |
|---|---|---|
| ITG (In This Together) | Experimental | 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. Receives: Behavioral: ITG (In This Together) |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Program feasibility: Recruitment
The number of participants recruited for the RCT (n=200)
Measured: 24 weeks
Program feasibility: Retention
The number of participants that will remain in the study at program end (80%)
Measured: 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
Measured: At intervention end, 6-weeks post baseline
Secondary outcomes (3)
Percent of participants reporting condom use during sex as assessed by self-report
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
Measured: At intervention end, 6-weeks post baseline
Percent of participants reporting abstinence as assessed by self-report
The percent of participants who report, at intervention end, not having sex versus having sex at least once, during the intervention period
Measured: At intervention end, 6-weeks post baseline
Percent of participants who have gotten an HIV test as assessed by self-report
The percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period
Measured: At intervention end, 6-weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start6 Dec 2017
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual AbstinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Internet Solutions for Kids Uganda
- Responsible party
- Sponsor
- Investigators
- Michele Ybarra, MPH PHD, Principal investigator, Center for Innovative Public Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729337
- Sponsor's protocol ID
- MH109296
- Status last verified
- Feb 2020
- First submitted
- 15 Mar 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33963477
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
- ClinicalTrials.gov ID
- NCT02729337
- Acronym / sponsor ID
- MH109296
- Conditions
- Sexual Abstinence, HIV, Contraceptive Usage
- Keywords
- technology, adolescent, developing country, hiv prevention, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- Internet Solutions for Kids Uganda
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITG (In This Together) | Experimental | Behavioral: 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- no other exclusion criteria will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITG (In This Together)Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age. | Behavioural | ITG (In This Together) |
Primary outcome
Program feasibility: Recruitment
Time frame: 24 weeks
The number of participants recruited for the RCT (n=200)
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%)
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
3 secondary outcomes
Percent of participants reporting condom use during sex as assessed by self-report
Time frame: 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
Percent of participants who have gotten an HIV test as assessed by self-report
Time frame: At intervention end, 6-weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 33963477Ybarra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Ybarra, MPH PHD principal investigator
Center for Innovative Public Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITG (In This Together) in people with Sexual Abstinence and HIV, run by Center for Innovative Public Health Research at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program feasibility: Recruitment (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.