Clinical trial NCT03167879: Integrating Safer Conception Counseling to Transform HIV Family Planning Services
Official title: Integrating Counseling to Transform HIV Family Planning Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safer Conception Intervention Trial
Keywords: family planning
safer conception
HIV
serodiscordant couples
Uganda
contraception
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
name: Makerere University
name: The AIDS Support Organization
name: University of Kansas
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-30
Enrollment: 389
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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. The model is factorial because the two active intervention arms will be combined and compared to usual care in some analyses.
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Used Dual Contraception or Safer Conception Method
timeFrame: Month 12
Secondary outcomes:
measure: Number Who Achieved Desired Pregnancy Status
timeFrame: Month 12
measure: Partner HIV Status
timeFrame: study end point (Month 12 or when learning of pregnancy)
Other outcomes:
measure: Cost-effectiveness of Safer Conception Counseling Intervention
timeFrame: 30 months of intervention implementation
Locations:
city: Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri
country: Uganda
facility: TASO
Study officials:
affiliation: RAND
name: Glenn Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.