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Integrating Safer Conception Counseling to Transform HIV Family Planning Services

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ClinicalTrials.gov Identifier: NCT03167879
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Children's Mercy Hospital Kansas City
Makerere University
The AIDS Support Organization (TASO)
University of Kansas
Information provided by (Responsible Party):
RAND

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE June 15, 2017
Actual Primary Completion Date May 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • pregnancy status [ Time Frame: Month 12 ]
    desired pregnancy status depending on what client chooses after safer conception consultation
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrating Safer Conception Counseling to Transform HIV Family Planning Services
Official Title  ICMJE Integrating Counseling to Transform HIV Family Planning Services
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Safer Conception Intervention Trial
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: SCC1--high intensity supervision
    Integration of safer conception counseling into family planning services, with intensive training and supervision
    Intervention: Behavioral: safer conception counseling
  • 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
    Intervention: Behavioral: safer conception counseling
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2019)
390
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
360
Actual Study Completion Date  ICMJE May 23, 2020
Actual Primary Completion Date May 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03167879
Other Study ID Numbers  ICMJE 2016-0560
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE
  • Children's Mercy Hospital Kansas City
  • Makerere University
  • The AIDS Support Organization (TASO)
  • University of Kansas
Investigators  ICMJE
Principal Investigator: Glenn Wagner, PhD RAND
PRS Account RAND
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP