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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049176
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborators:
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

Brief Summary:
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 or disease Intervention/treatment
HIV Infections Drug: PrEP (Truvada) Drug: Antiretrovirals Procedure: Semen washing Procedure: Artificial vaginal 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.

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Uptake of safer conception strategies [ Time Frame: 12 months ]
    proportion of couples choosing the strategy

  2. Acceptability of safer conception strategies [ Time Frame: 12 months ]
    proportion of couples remaining on strategy; reports of satisfaction

  3. Adherence to safer conception strategies [ Time Frame: 12 months ]
    proportion of couples with high adherence to strategy


Secondary Outcome Measures :
  1. Effectiveness of safer conception strategies on HIV prevention [ Time Frame: 12 months ]
    incidence of HIV

  2. Effectiveness of safer conception strategies on achieving pregnancy [ Time Frame: 12 months ]
    incidence of pregnancy

  3. costs of providing safer conception services [ Time Frame: 12 months ]
    costs

  4. cost-effectiveness of safer conception strategies [ Time Frame: 12 months ]
    model the cost effectiveness of various combinations of safer conception strategies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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

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): NCT03049176


Locations
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Zimbabwe
UZCHS-UCSF CTRC Zengeza Clinical Research Site
Harare, Zimbabwe
Sponsors and Collaborators
University of California, San Francisco
UZ-UCSF Collaborative Research Programme
National Institute of Mental Health (NIMH)
Gilead Sciences
Investigators
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Principal Investigator: Joelle M Brown, PhD, MPH University of California, San Francisco
Principal Investigator: Felix Mhlanga, MBChB, MMed UZ-UCSF Collaborative Research Programme
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joelle Brown, MPH, PhD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03049176    
Other Study ID Numbers: A126763
K01MH100994 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available at the end of the study on an online repository.

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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:
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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
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents