Integrating Safer Conception Counseling to Transform HIV Family Planning Services

Not Applicable

Completed

Conditions: Safer Conception Intervention Trial

Interventions: Behavioral: safer conception counseling

Registration Number: NCT03167879

Lead Sponsor: 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 389

Inclusion Criteria

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.

Exclusion Criteria

Female client (or partner of male client) is pregnant

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SCC1--high intensity supervision	safer conception counseling	Integration of safer conception counseling into family planning services, with intensive training and supervision
SCC2-- low intensity supervision	safer conception counseling	Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Used Dual Contraception or Safer Conception Method	Month 12	Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention

Secondary Outcome Measures

Name	Time	Method
Number Who Achieved Desired Pregnancy Status	Month 12	Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation
Partner HIV Status	study end point (Month 12 or when learning of pregnancy)	Partner HIV status as determined by HIV antibody test conducted by study