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| Name | Class |
|---|---|
| MU-JHU CARE | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Routine Care plus individual support | Experimental | Routine Care plus enhanced individual support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced group support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | at one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Mirembe, MMED, PhD | MU-JHU Care Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUJHU CARE Ltd | Kampala | Wakiso DIstrict | Uganda |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2016 | May 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| enhanced individual support | Behavioral | 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. |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |