Pregnancy RelatedNCT05022277
Empowering Girls: Health-seeking Behavior, Staying in School, and Preventing Risky Sex
A study testing Low tech health SMS messages and Low tech health Phone + SMS messages in people with Pregnancy Related and Behavior, Health, run by Young 1ove at 1 site in Botswana.
Trial summary
This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Behavior, Health
- What is being tested?
- Low tech health SMS messages and Low tech health Phone + SMS messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteBotswana
- Study dates
- 28 Apr 2020to 20 Oct 2021
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent who provided their phone number to Young 1ove staff when prompted by their school; or their siblings/ other adolescents living in the same household.
- Parents and students consented to participate.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Botswana1 site, 1 recruiting
- Recruiting
Young 1ove
Gaborone
Efua Bortsie, ebortsie@young1ove.org
About this study
Official title: Empowering Girls: Health-seeking Behavior, Staying in School and Preventing Risky Sex
This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships.
The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.
- Conditions
- Pregnancy Related, Behavior, Health
- Being tested
- Low tech health SMS messages, Low tech health Phone + SMS messages
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tech health SMS messagesBehavioural
Weekly health-related SMS messages are provided to adolescents.
Low tech health Phone + SMS messagesBehavioural
Weekly health-related phone calls plus SMS messages are provided to adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Phone-based intervention Plus SMS messages | Experimental | Not described Receives: Behavioral: Low tech health Phone + SMS messages |
| SMS messages only | Experimental | Not described Receives: Behavioral: Low tech health SMS messages |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Share of students that have been or are pregnant and/or have dropped out of school
These two outcomes (using school administrative data on whether students have dropped out of school and were pregnant) will be combined into a composite variable equal to 1 if the student has become pregnant and/or has dropped out of school.
Measured: ~6 months post-program
Share of students with the accurate belief that older partners have the highest risk of HIV compared to younger partners.
Indicator variable from the survey question wording: "Who do you think has the highest risk of infecting you with HIV?"
Measured: ~4 weeks post program
Secondary outcomes (2)
Share of students reporting that they make the final decision in their life about visiting a Sexual and reproductive health clinic
Indicator variable from the survey question response
Measured: ~4 weeks post program
Share of students reporting that if they or their partner were pregnant, they would tell the data collector
Indicator variable coded 1 if student answered likely or very likely to 'If you were pregnant, how likely would you be to tell me?'
Measured: ~4 weeks post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start28 Apr 2020
- Primary completion20 Oct 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Young 1ove
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Noam Angrist, PhD, Study chair, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022277
- Sponsor's protocol ID
- Y1HPDME2021
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Girls: Health-seeking Behavior, Staying in School and Preventing Risky Sex
- ClinicalTrials.gov ID
- NCT05022277
- Acronym / sponsor ID
- Y1HPDME2021
- Conditions
- Pregnancy Related, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Young 1oveUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 26 Aug 2021 (actual)
- 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.
This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships.
The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phone-based intervention Plus SMS messages | Experimental | Behavioral: Low tech health Phone + SMS messages |
| SMS messages only | Experimental | Behavioral: Low tech health SMS messages |
| Control | No intervention | – |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescent who provided their phone number to Young 1ove staff when prompted by their school; or their siblings/ other adolescents living in the same household.
- Parents and students consented to participate.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Low tech health SMS messagesWeekly health-related SMS messages are provided to adolescents. | Behavioural | SMS messages only |
| Low tech health Phone + SMS messagesWeekly health-related phone calls plus SMS messages are provided to adolescents. | Behavioural | Phone-based intervention Plus SMS messages |
Primary outcome
Share of students that have been or are pregnant and/or have dropped out of school
Time frame: ~6 months post-program
These two outcomes (using school administrative data on whether students have dropped out of school and were pregnant) will be combined into a composite variable equal to 1 if the student has become pregnant and/or has dropped out of school.
Share of students with the accurate belief that older partners have the highest risk of HIV compared to younger partners.
Time frame: ~4 weeks post program
Indicator variable from the survey question wording: "Who do you think has the highest risk of infecting you with HIV?"
2 secondary outcomes
Share of students reporting that they make the final decision in their life about visiting a Sexual and reproductive health clinic
Time frame: ~4 weeks post program
Share of students reporting that if they or their partner were pregnant, they would tell the data collector
Time frame: ~4 weeks post program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Noam Angrist, PhD study chair
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low tech health SMS messages and Low tech health Phone + SMS messages in people with Pregnancy Related and Behavior, Health, run by Young 1ove at 1 site in Botswana.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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 Botswana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noam Angrist, PhD (+18572250117, nangrist@young1ove.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Share of students that have been or are pregnant and/or have dropped out of school (time frame: ~6 months post-program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2021.