Helping Men Have Healthy Babies
Primary Purpose
HIV/AIDS, HIV Prevention
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Safer Conception for Men with At Risk Partners
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Safer Conception Intervention
Arm Description
Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.
Outcomes
Primary Outcome Measures
HIV RNA Suppression
Proportion of men achieving HIV-RNA suppression
Secondary Outcome Measures
Uptake of ART
The proportion of men who initiate or continue ART
Uptake of HIV-serostatus disclosure
The proportion of men who report disclosure of HIV serostatus to pregnancy partner
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
Full Information
NCT ID
NCT03818984
First Posted
December 7, 2018
Last Updated
April 15, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03818984
Brief Title
Helping Men Have Healthy Babies
Official Title
Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2015 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HIV Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Safer Conception Intervention
Arm Type
Experimental
Arm Description
Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.
Intervention Type
Behavioral
Intervention Name(s)
Safer Conception for Men with At Risk Partners
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV RNA Suppression
Description
Proportion of men achieving HIV-RNA suppression
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Uptake of ART
Description
The proportion of men who initiate or continue ART
Time Frame
12 weeks
Title
Uptake of HIV-serostatus disclosure
Description
The proportion of men who report disclosure of HIV serostatus to pregnancy partner
Time Frame
12 weeks
Title
Use of timing condomless sex to peak fertility
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
35507406
Citation
Matthews LT, Psaros C, Mathenjwa M, Mosery N, Greener LR, Khidir H, Hovey JR, Pratt MC, Harrison A, Bennett K, Bangsberg DR, Smit JA, Safren SA. Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study. JMIR Form Res. 2022 May 4;6(5):e34262. doi: 10.2196/34262.
Results Reference
derived
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Helping Men Have Healthy Babies
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