N/A
N=389
Integrating Safer Conception Counseling to Transform HIV Family Planning Services
Safer Conception Intervention Trial
Bottom Line
View on ClinicalTrials.gov: NCT03167879 ↗Enrolled (actual)
389
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Who Used Dual Contraception or Safer Conception Method — 35; 19; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- safer conception counseling (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- RAND
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Used Dual Contraception or Safer Conception Method |
35; 19; 9 | — |
| SECONDARY Number Who Achieved Desired Pregnancy Status |
32; 29; 27 | — |
| SECONDARY Partner HIV Status |
0; 1; 0; 129; 129; 130 | — |
Summary
This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.
Eligibility Criteria
Inclusion Criteria
- HIV+ client of TASO
- Client if of reproductive age (males age 15-60; females age 15-45).
- Has a partner with whom the client is considering having a child.
- If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
- Partner with whom the client is considering having a child is HIV-negative.
- Client reports that their partner is aware of the client being HIV-positive.
Exclusion Criteria
- Female client (or partner of male client) is pregnant
Data sourced from ClinicalTrials.gov (NCT03167879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.