Integrating Safer Conception Counseling to Transform HIV Family Planning Services

Study Overview
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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.

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).

Official Title
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Integrating Counseling to Transform HIV Family Planning Services

Conditions
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Safer Conception Intervention Trial

Intervention / Treatment
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* Behavioral: safer conception counseling


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCC1--high intensity supervision<br>Integration of safer conception counseling into family planning services, with intensive training and supervision | Behavioral: safer conception counseling<br>* 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.<br>* Other names: SCC;|
| Experimental: SCC2-- low intensity supervision<br>Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach | Behavioral: safer conception counseling<br>* 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.<br>* Other names: SCC;|
| No Intervention: Usual care family planning services<br>Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family planning, safer conception, HIV, serodiscordant couples, Uganda, contraception