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Integrating Safer Conception Counseling to Transform HIV Family Planning Services

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ClinicalTrials.gov Identifier: NCT03167879
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborators:
Children's Mercy Hospital, University of Missouri, Kansas City
Makerere University
The AIDS Support Organization (TASO)
University of Kansas
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
Safer Conception Intervention Trial Behavioral: safer conception counseling Phase 2 Phase 3

Detailed Description:
Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to support safer conception, despite ~40% of HIV+ women in sub-Saharan Africa (SSA) becoming pregnant post HIV diagnosis. Antiretroviral therapy (ART) greatly reduces the transmission risks associated with childbearing, but many PLHA are either not on ART or not adequately adherent; hence the need for using safer conception methods (SCM) such as manual self-insemination and timed unprotected intercourse. This cluster RCT will compare (1) a comprehensive FP program that incorporates a structured, multi-component SCC intervention (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at 6 HIV clinics operated by TASO Uganda. The 3-arm design, together with the planned cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP services that differ on level of intensity, thereby informing MoH policy and resource allocation. Sixty clients in HIV serodiscordant relationships who express childbearing desires at recruitment will be enrolled at each site (n=360) and followed for 12 months or completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those trying to conceive) or dual contraception (those who decide against pregnancy).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Integrating Counseling to Transform HIV Family Planning Services
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCC1--high intensity supervision
Integration of safer conception counseling into family planning services, with intensive training and supervision
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.
Other Name: SCC

Experimental: SCC2-- low intensity supervision
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
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.
Other Name: SCC

No Intervention: Usual care family planning services
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention



Primary Outcome Measures :
  1. Use of dual contraception or safer conception method [ Time Frame: Month 12 ]
    Use of either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention


Secondary Outcome Measures :
  1. pregnancy status [ Time Frame: Month 12 ]
    desired pregnancy status depending on what client chooses after safer conception consultation

  2. partner HIV status [ Time Frame: study end point (Month 12 or when learning of pregnancy) ]
    Partner HIV status as determined by HIV antibody test conducted by study



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV+ client of TASO
  2. Client if of reproductive age (males age 15-60; females age 15-45).
  3. Has a partner with whom the client is considering having a child.
  4. 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.
  5. Partner with whom the client is considering having a child is HIV-negative.

5. Client reports that their partner is aware of the client being HIV-positive.

Exclusion Criteria:

1. Female client (or partner of male client) is pregnant


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167879


Contacts
Contact: Glenn Wagner, PhD +1-310-393-0411 ext 7698 gwagner@rand.org
Contact: Rhoda Wanyenze, MD +256-772419762 rwanyenze@musph.ac.ug

Locations
Uganda
TASO Recruiting
Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri, Uganda
Contact: Violet gwokyalya, MD       vgwokyalya@musph.ac.ug   
Sponsors and Collaborators
RAND
Children's Mercy Hospital, University of Missouri, Kansas City
Makerere University
The AIDS Support Organization (TASO)
University of Kansas
Investigators
Principal Investigator: Glenn Wagner, PhD RAND

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03167879     History of Changes
Other Study ID Numbers: 2016-0560
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A data sharing plan is in place to provide a de-identified dataset to researchers who request access or through an NIH-affiliated repository

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAND:
family planning
safer conception
HIV
serodiscordant couples
Uganda
contraception