Integrating Safer Conception Counseling to Transform HIV Family Planning Services

RanD

Status: Completed

Conditions: Safer Conception Intervention Trial

Treatments: Behavioral: safer conception counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03167879

R01HD090981 (U.S. NIH Grant/Contract)

2016-0560

Details and patient eligibility

About

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.

Full 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).

Enrollment: 389 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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.

6. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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389 participants in 3 patient groups

SCC1--high intensity supervision

Experimental group

Description:

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

Treatment:

Behavioral: safer conception counseling

SCC2-- low intensity supervision

Experimental group

Description:

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

Treatment:

Behavioral: safer conception counseling

Usual care family planning services

No Intervention group

Description:

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