Integrating Safer Conception Counseling to Transform HIV Family Planning Services

Safer Conception Intervention Trial Clinical Trial

Official title:

Integrating Counseling to Transform HIV Family Planning Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167879
• Other study ID #: 2016-0560
• Secondary ID: R01HD090981
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: May 23, 2020

Study information

• Verified date: October 2022
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: May 23, 2020
• Est. primary completion date: May 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Safer Conception Intervention Trial

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Uganda	TASO	Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri

Sponsors (6)

Lead Sponsor	Collaborator
RAND	Children's Mercy Hospital Kansas City, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Makerere University, The AIDS Support Organization (TASO), University of Kansas

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness of Safer Conception Counseling Intervention	We tracked all costs associated with implementing SCC1 and SCC2 beyond those of existing FP services, such as labor costs associated with SCC sessions and consults with FP nurses, supervision of the FP nurses (in SCC1), contraceptives and SCM client kits, and cost of intervention materials (posters, SCM instructional videos). We assessed the costs for accurate use of SCM on its own among those trying to conceive. Because supervisors in SCC1 were research staff with significantly higher salaries than the MoH supervisors in SCC2, we conducted an additional more realistic "scale-up scenario" showing the costs of SCC1 if its supervisors' salaries were the same as the MoH supervisors' salaries. The cost-effectiveness ratio was calculated as the cost per participant divided by the relative effect size in that group compared to the usual care control.	30 months of intervention implementation
Primary	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	Number Who Achieved Desired Pregnancy Status	Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation	Month 12
Secondary	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)