Integrating Safer Conception Counseling to Transform HIV Family Planning Services

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-05-23

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Safer Conception Intervention Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SCC1--high intensity supervision

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

Group Type EXPERIMENTAL

safer conception counseling

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

safer conception counseling

Intervention Type BEHAVIORAL

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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SCC

Eligibility Criteria

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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.