NCT03167879

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2020

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 21, 2022

Completed
Last Updated

November 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

May 23, 2017

Results QC Date

July 9, 2022

Last Update Submit

October 27, 2022

Conditions

Safer Conception Intervention Trial

Keywords

family planningsafer conceptionHIVserodiscordant couplesUgandacontraception

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Used Dual Contraception or Safer Conception Method

    Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention

    Month 12

Secondary Outcomes (2)

  • Number Who Achieved Desired Pregnancy Status

    Month 12

  • Partner HIV Status

    study end point (Month 12 or when learning of pregnancy)

Other Outcomes (1)

  • Cost-effectiveness of Safer Conception Counseling Intervention

    30 months of intervention implementation

Study Arms (3)

SCC1--high intensity supervision

EXPERIMENTAL

Integration of safer conception counseling into family planning services, with intensive training and supervision

Behavioral: safer conception counseling

SCC2-- low intensity supervision

EXPERIMENTAL

Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach

Behavioral: safer conception counseling

Usual care family planning services

NO INTERVENTION

Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention

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.

Also known as: SCC
SCC1--high intensity supervisionSCC2-- low intensity supervision

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Female client (or partner of male client) is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TASO

Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri, Uganda

Location

Related Publications (3)

  • Wagner GJ, Wanyenze RK, Beyeza-Kashesya J, Gwokyalya V, Hurley E, Mindry D, Finocchario-Kessler S, Nanfuka M, Tebeka MG, Saya U, Booth M, Ghosh-Dastidar B, Linnemayr S, Staggs VS, Goggin K. "Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches. Implement Sci. 2021 Apr 15;16(1):41. doi: 10.1186/s13012-021-01109-z.

    PMID: 33858462DERIVED

  • Wagner GJ, Mindry D, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Wanyenze RK, Nanfuka M, Tebeka MG, Goggin K. Reproductive intentions and corresponding use of safer conception methods and contraception among Ugandan HIV clients in serodiscordant relationships. BMC Public Health. 2021 Jan 19;21(1):156. doi: 10.1186/s12889-021-10163-7.

    PMID: 33468072DERIVED

  • Goggin K, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Birungi J, Mindry D, Wanyenze RK, Wagner GJ. Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda. Implement Sci. 2018 Aug 14;13(1):110. doi: 10.1186/s13012-018-0793-y.

    PMID: 30107843DERIVED

Limitations and Caveats

No survey data were collected from the partner of the index participant, except for female partners of male participants who were briefly interviewed on contraception use. Data reported by the female partners were recorded as data for the male participant. These female partner participants are not included in the number enrolled.

Results Point of Contact

Title
Dr. Glenn Wagner
Organization
RAND Corporation
gwagner@rand.org
310-393-0411

Study Officials

  • Glenn Wagner, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: This 3-arm cluster RCT will compare (1) a multi-component intervention that integrates safer conception counseling (SCC) into existing family planning (FP) services and provides intensive training and supervision (SCC1), (2) the integration of the same intervention as in (1) into FP services but with a less intensive training and supervision model that mimics the Ministry of Health approach, and (3) usual care FP services, at 6 HIV clinics (2 per arm) operated by TASO Uganda. The model is factorial because the two active intervention arms will be combined and compared to usual care in some analyses.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

June 15, 2017

Primary Completion

May 23, 2020

Study Completion

May 23, 2020

Last Updated

November 21, 2022

Results First Posted

November 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

A data sharing plan is in place to provide a de-identified dataset to researchers who request access or through an NIH-affiliated repository

Locations

UG(1)