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Trial record 33 of 5992 for:    zero

Getting to Zero: Safer Conception Programming Among HIV Sero-different Couples in Uganda (G2Z)

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ClinicalTrials.gov Identifier: NCT03895619
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Massachusetts General Hospital
Information provided by (Responsible Party):
Angela Kaida, Simon Fraser University

Brief Summary:
Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods. In particular, there is a lack of safer conception services focused on engaging men living with HIV. Given known gender inequities in childbearing decision-making and HIV risk, it is critical that safer conception services deliver programming that engages men living with HIV and their HIV sero-different partners. The Healthy Families program, based at the ISS Clinic at Mbarara Regional Referral Hospital, offers client-centered safer conception care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use Antiretroviral Therapy (ART), adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among 50 men living with HIV and their HIV sero-different partners. Investigators will also assess men's retention in HIV care and HIV transmission risk to partners and infants. This is a one-year mixed-methods prospective pilot research study, which will use electronic chart review data, longitudinal survey data (from the male index and female partner participant), and qualitative data from in-depth semi-structured interviews to meet study objectives. By demonstrating safer conception uptake and impact on HIV transmission risks to partners and infants, investigators aim to inform HIV and reproductive health policy in Uganda and globally.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Safer conception strategies Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Proof of Concept Research
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Getting to Zero: Safer Conception Programming to Eliminate Sexual and Perinatal HIV Transmission Among HIV Sero-different Couples in Uganda
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 26, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Men living with HIV
Uptake of safer conception strategies among men living with HIV and/or their female partners
Other: Safer conception strategies
Individuals and couples adopt safer conception strategies including HIV-serostatus disclosure to partner, ART uptake and adherence and HIV-RNA suppression, STI testing and treatment, timing condomless sex to peak fertility, partner ARV use (ART if living with HIV, PrEP if HIV negative), and contraception until ready to conceive.




Primary Outcome Measures :
  1. Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs [ Time Frame: 1.5 year ]
    We will document the number of participants who return to their clinic with their female pregnancy partner to attend Safer Conception Counselling. We will also document the type of strategy chosen.


Secondary Outcome Measures :
  1. Types of factors contributing to uptake of safer conception strategies among men living with HIV [ Time Frame: 1.5 year ]
    The reasons why men chose to use safer conception strategies will be better understood using unadjusted and adjusted logistic regression models (with 95% confidence intervals)

  2. Number of men living with HIV retained in care who are part of the safer conception intervention. [ Time Frame: 1.5 year ]
    Will use Kaplan-Meier methods to measure time to index loss from care

  3. HIV transmission incidence among HIV-affected individuals and couples where the male partner is living with HIV and engaged in the safer conception intervention. [ Time Frame: 1.5 year ]
    Will use Kaplan-Meier methods to measure partner HIV-seroconversion.

  4. Periconception HIV transmission incidence among HIV-affected individuals and couples. [ Time Frame: 1.5 year ]
    Cumulative incidence of pregnancy will be calculated as the total number of pregnancies over the follow-up period by person-years of follow-up.

  5. HIV incidence among female partners of men living with HIV engaged in the safer conception intervention. [ Time Frame: 1.5 year ]
    Will analyze interview data using content analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For enrollment in the Getting to Zero study, eligibility criteria for the index participant include the following:

  1. Identify as male
  2. HIV-positive
  3. Report personal or partner desire to have a child in the next year
  4. Identified pregnancy partner is reported to be HIV-negative or he doesn't know her HIV serostatus.
  5. Aged 18 years or older.
  6. Be naïve to the Healthy Families program.
  7. Live within 60km of the ISS clinic and not planning to relocate to an area incompatible with an ability to attend the clinic over a 1 year follow-up period.
  8. Able and willing to participate in the informed consent process.

Men living with HIV enrolled in the Getting to Zero study (index participants) will be asked for their consent to contact their partners to determine eligibility, interest, and willingness to participate in the Getting to Zero study. Partner participants must meet the following inclusion criteria:

  1. Identify as a partner of an enrolled male Getting to Zero participant
  2. Aged 18 years or older
  3. Able and willing to participate in the informed consent process.

These participants will be referred to as the "partner". If the female partner is identified as HIV-positive after the male index participant enrolls in the Getting to Zero study, both partners remain eligible to participate.

Exclusion Criteria for Index Participant:

  1. Identify as female
  2. HIV-negative
  3. Does not report personal or partner desire to have a child in the next year
  4. Identified pregnancy partner is reported to be HIV-positive
  5. Under age 18 years.
  6. Be a patient of the Healthy Families program.
  7. Live greater than 60km of the ISS clinic and planning to relocate to an area incompatible with attending the clinic over a 1 year follow-up period.
  8. Unable and unwilling to participate in the informed consent process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895619


Contacts
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Contact: Angela Kaida, PhD 778-782-9068 angela_kaida@sfu.ca

Locations
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Uganda
Immune Suppression Syndrome (ISS) Clinic at the Mbarara Regional Referral Hospital (MRRH) Recruiting
Mbarara, Uganda
Contact: Mwebesa Bosco Bwana, MBChB    256 772 308895    bbwana@must.ac.ug   
Sponsors and Collaborators
Simon Fraser University
Mbarara University of Science and Technology
Massachusetts General Hospital

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Responsible Party: Angela Kaida, Associate Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT03895619     History of Changes
Other Study ID Numbers: 2018s0272
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases