CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 389 enrolled
Drug / intervention
safer conception counselingbehavioral
Likely dose
Not stated in record
Key inclusion· 6
  • ✓HIV-positive client of TASO
  • ✓Reproductive age: males 15–60 years, females 15–45 years
  • ✓In a stable partnership with someone the client is considering having a child with
  • ✓Partner is HIV-negative
Key exclusion· 1
  • ✕Female client or female partner of male client is pregnant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03167879
NCT03167879N/ACompleted
CompareCT.gov

Integrating Counseling to Transform HIV Family Planning Services

RAND·interventional·Posted May 30, 2017·Updated Nov 21, 2022

In Brief

A clinical study evaluating safer conception counseling for Safer Conception Intervention Trial. Completed, enrolled 389 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafer Conception Intervention Trial
CountriesUganda
CollaboratorsChildren's Mercy Hospital Kansas City, Makerere University, The AIDS Support Organization, University of Kansas, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartJun 15, 2017
Primary CompletionMay 23, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.1 years ago

Interventions

safer conception counselingbehavioral

Multi-component counseling to help HIV-affected couples to make an informed decision about childbearing, and to provide counseling to use contraception or safer conception methods, depending on whether the couples chooses to seek or prevent pregnancy after initial consultation.