Helping Men Have Healthy Babies

HIV/AIDS Clinical Trial

Official title:

Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818984
• Other study ID #: 2013P002693
• Status: Completed
• Phase: N/A
• Start date: November 6, 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: April 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize sexual HIV transmission risks while allowing for conception. The study will evaluate a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on the investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

Description:

The study will evaluate and test a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on a Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

The researchers will conduct an open pilot to refine the intervention. The study will enroll men who want to have children with uninfected or unknown status female partners. Men will participate in three study sessions offering motivational interviewing and problem solving to help men develop a plan to have a healthy baby. The counseling will explore safer conception options including safe disclosure, delaying conception attempts until on ART with viral suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability, feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Identifies as male

• Not on ART, or initiated ART within the past 3 months

• HIV-positive and status known for at least 1 (one) month,

• in care/patient at iThembalabantu clinic

• want to have a child in the next year,

• with a stable sexual pregnancy partner for at least 6 months,

• their pregnancy partner should be HIV-uninfected or HIV-status unknown,

• their pregnancy partner should not be known to be currently pregnant,

• have their own/ a mobile phone

• be fluent in either English or isiZulu and,

• able to participate in informed consent process

• not sterilized or known to be infertile

Related Conditions & MeSH terms

• HIV Prevention
• HIV/AIDS

Intervention

Behavioral:
• Safer Conception for Men with At Risk Partners
CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV RNA Suppression	Proportion of men achieving HIV-RNA suppression	12 weeks
Secondary	Uptake of ART	The proportion of men who initiate or continue ART	12 weeks
Secondary	Uptake of HIV-serostatus disclosure	The proportion of men who report disclosure of HIV serostatus to pregnancy partner	12 weeks
Secondary	Use of timing condomless sex to peak fertility	Through SMS surveys to assess weekly sexual behavior the study will evaluate the proportion of men who attempt to limit condomless sex to peak fertility	12 weeks