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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03049176 |
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Date of registration:
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07/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)
SAFER |
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Scientific title:
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The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples |
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Date of first enrolment:
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March 13, 2017 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03049176 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Joelle M Brown, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Name:
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Felix Mhlanga, MBChB, MMed |
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Address:
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Telephone:
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Email:
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Affiliation:
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UZ-UCSF Collaborative Research Programme |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: PrEP (Truvada)
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Drug: Antiretrovirals
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Procedure: Semen washing
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Procedure: Artificial vaginal insemination
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Primary Outcome(s)
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Acceptability of safer conception strategies
[Time Frame: 12 months]
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Uptake of safer conception strategies
[Time Frame: 12 months]
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Adherence to safer conception strategies
[Time Frame: 12 months]
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Secondary Outcome(s)
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costs of providing safer conception services
[Time Frame: 12 months]
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cost-effectiveness of safer conception strategies
[Time Frame: 12 months]
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Effectiveness of safer conception strategies on achieving pregnancy
[Time Frame: 12 months]
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Effectiveness of safer conception strategies on HIV prevention
[Time Frame: 12 months]
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Secondary ID(s)
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K01MH100994
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A126763
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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