PregnancyNCT02845284
'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
A study testing enhanced group support and enhanced individual support in people with Pregnancy and Human Immunodeficiency Virus, run by Johns Hopkins University at 1 site in Uganda.
Trial summary
This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Human Immunodeficiency Virus, Sexually Transmitted Diseases
- What is being tested?
- enhanced group support and enhanced individual support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteUganda
- Study dates
- 30 Mar 2016to 30 Dec 2017
- 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant at ≥28 weeks of gestation
- Agreeing to provide written informed consent to be screened for and take part in the study
- Agreeing to provide adequate locator information with residence within 30 km
- Agreeing to a home visit
- Agreeing to come for follow up visits and to receive study follow up phone calls
Who cannot join
- Serious illness or social conditions that would prevent adherence to study requirements
- High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.
Read the detailed description
The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C\&T and availability of partner C\&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.
The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.
- Being tested
- enhanced group support, enhanced individual support
- Keywords
- adolescent, reproductive health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced group supportBehavioural
Routine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
enhanced individual supportBehavioural
Routine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C\&T and family planning C\&T services on request. |
| Routine Care plus group support | Experimental | Routine Care plus enhanced group support Receives: Behavioral: enhanced group support |
| Routine Care plus individual support | Experimental | Routine Care plus enhanced individual support Receives: Behavioral: enhanced individual support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of consistent condom-use and use of an effective family planning method method
A log-binomial regression model will be used to obtain the prevalence rate ratios.
Measured: A comparison of this binary outcome will be conducted at one year.
Incidence of any Sexually Transmitted Infection
Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start30 Mar 2016
- Primary completion1 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE
- Responsible party
- Sponsor
- Investigators
- Florence Mirembe, MMED, PhD, Principal investigator, MU-JHU Care Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845284
- Sponsor's protocol ID
- IRB00061475
- Status last verified
- May 2019
- First submitted
- 20 Jul 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
- ClinicalTrials.gov ID
- NCT02845284
- Acronym / sponsor ID
- IRB00061475
- Keywords
- adolescent, reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- MU-JHU CARE
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 27 Jul 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.
This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.
Detailed description
The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C\&T and availability of partner C\&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.
The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C\&T and family planning C\&T services on request. |
| Routine Care plus group support | Experimental | Behavioral: enhanced group supportRoutine Care plus enhanced group support |
| Routine Care plus individual support | Experimental | Behavioral: enhanced individual supportRoutine Care plus enhanced individual support |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant at ≥28 weeks of gestation
- Agreeing to provide written informed consent to be screened for and take part in the study
- Agreeing to provide adequate locator information with residence within 30 km
- Agreeing to a home visit
- Agreeing to come for follow up visits and to receive study follow up phone calls
Key exclusion criteria (2 listed)
- Serious illness or social conditions that would prevent adherence to study requirements
- High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)
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 |
|---|---|---|
| enhanced group supportRoutine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery. | Behavioural | Routine Care plus group support |
| enhanced individual supportRoutine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery. | Behavioural | Routine Care plus individual support |
Primary outcome
Composite measure of consistent condom-use and use of an effective family planning method method
Time frame: A comparison of this binary outcome will be conducted at one year.
A log-binomial regression model will be used to obtain the prevalence rate ratios.
Incidence of any Sexually Transmitted Infection
Time frame: at one year
Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
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 17 May 2019.
- 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.
Florence Mirembe, MMED, PhD principal investigator
MU-JHU Care Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced group support and enhanced individual support in people with Pregnancy and Human Immunodeficiency Virus, run by Johns Hopkins University 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 5 inclusion and 2 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 17 May 2019. 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?
Composite measure of consistent condom-use and use of an effective family planning method method (time frame: A comparison of this binary outcome will be conducted at one year.). 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 17 May 2019.