Integrating Safer Conception Counseling to Transform HIV Family Planning Services

NCT03167879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2022-11-21

Study results available
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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.

Conditions

  • Safer Conception Intervention Trial

Interventions

BEHAVIORAL

safer conception counseling

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.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    collaborator OTHER
  • Makerere University

    collaborator OTHER
  • The AIDS Support Organization

    collaborator OTHER
  • University of Kansas

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • RAND

    lead OTHER

Principal Investigators

  • Glenn Wagner, PhD · RAND

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2020-05-23
Completion
2020-05-23

Countries

  • Uganda

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167879 on ClinicalTrials.gov