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Clinical Trials

MainTitle

The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER) (SAFER)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2017 by Joelle Brown, MPH, PhD, University of California, San Francisco

Sponsor
University of California, San Francisco

Collaborator
UZ-UCSF Collaborative Research Programme
National Institute of Mental Health (NIMH)
Gilead Sciences

Information provided by (Responsible Party)
Joelle Brown, MPH, PhD, University of California, San Francisco

ClinicalTrials.gov Identifier
NCT03049176

First received: February 7, 2017
Last updated: April 18, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

Condition Intervention
HIV Infections

Drug : PrEP (Truvada)
Drug : Antiretrovirals
Procedure : Semen washing
Procedure : Artificial vaginal insemination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples

Further study details as provided by Joelle Brown, MPH, PhD, University of California, San Francisco:

Primary Outcome Measures

  • Uptake of safer conception strategies [ Time Frame: 12 months ]
    proportion of couples choosing the strategy
  • Acceptability of safer conception strategies [ Time Frame: 12 months ]
    proportion of couples remaining on strategy; reports of satisfaction
  • Adherence to safer conception strategies [ Time Frame: 12 months ]
    proportion of couples with high adherence to strategy
Secondary Outcome Measures:
  • Effectiveness of safer conception strategies on HIV prevention [ Time Frame: 12 months ]
    incidence of HIV
  • Effectiveness of safer conception strategies on achieving pregnancy [ Time Frame: 12 months ]
    incidence of pregnancy
  • costs of providing safer conception services [ Time Frame: 12 months ]
    costs
  • cost-effectiveness of safer conception strategies [ Time Frame: 12 months ]
    model the cost effectiveness of various combinations of safer conception strategies

Estimated Enrollment: 160
Study Start Date: March 13, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
Drug: PrEP (Truvada)

oral, daily Truvada for HIV-negative participants

Other Name: emtricitabine/tenofovir disoproxil fumarate
Drug: Antiretrovirals

oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

Other Name: ART
Procedure: Semen washing

collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination

HIV+female/HIV-male
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
Drug: PrEP (Truvada)

oral, daily Truvada for HIV-negative participants

Other Name: emtricitabine/tenofovir disoproxil fumarate
Drug: Antiretrovirals

oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

Other Name: ART
Procedure: Artificial vaginal insemination

collection of semen from an HIV-negative man, followed by intravaginal insemination

Detailed Description:

The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 35 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant

Criteria

Inclusion Criteria:
For all couples:

  • Couple expresses a desire to conceive
  • Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months
  • Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months
  • Willing to use at least one safer conception strategy
  • For men, age ≥18 years. For women, age 18 - 35 years;
  • Able and willing to provide written informed consent

  • For HIV-uninfected members of the couple
  • HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit
  • Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min

  • For HIV-infected members of the couple
  • HIV-positive based on parallel positive HIV rapid tests, based on national algorithm
  • No current AIDS-defining illness


Exclusion Criteria:
  • Amenorrheic
  • Currently pregnant
  • Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.
  • History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility
  • Currently on any concomitant medication that requires the participant to avoid use of
PrEP

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03049176

Contacts

Contact:   Thandiwe Chirenda +263 772460038 tchirenda@uz-ucsf.co.zw
Contact:   Felix Mhlanga, MBChB, MMed + 263 772 335 232 fmhlanga@uz-ucsf.co.zw

Locations

Zimbabwe
UZ-UCSF Zengeza Clinical Research Site Recruiting
Harare, Zimbabwe
Contact: Felix Mhlanga    263-772-335-232    fmhlanga@uz-ucsf.co.zw

Sponsors and Collaborators

University of California, San Francisco
UZ-UCSF Collaborative Research Programme
National Institute of Mental Health (NIMH)
Gilead Sciences

Investigators

Principal Investigator: Joelle M Brown, PhD, MPH University of California, San Francisco
Principal Investigator: Felix Mhlanga, MBChB, MMed UZ-UCSF Collaborative Research Programme
More Information

More Information


Responsible Party: Joelle Brown, MPH, PhD, Principal Investigator, University of California, San Francisco  
ClinicalTrials.gov Identifier: NCT03049176   History of Changes  
Other Study ID Numbers: A126763  
  K01MH100994  
Study First Received: February 7, 2017  
Last Updated: April 18, 2017  
Individual Participant Data    
Plan to Share IPD: Yes  

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

Keywords provided by Joelle Brown, MPH, PhD, University of California, San Francisco:

HIV-discordant couple
ART
PrEP
semen washing
artificial vaginal insemination
safer conception
pregnancy

Additional relevant MeSH terms:
HIV Infections
Emtricitabine
Tenofovir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.