- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03049176
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER) (SAFER)
27. september 2019 opdateret af: Joelle Brown, MPH, PhD, University of California, San Francisco
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
46
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Harare, Zimbabwe
- UZCHS-UCSF CTRC Zengeza Clinical Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
|
oral, daily Truvada for HIV-negative participants
Andre navne:
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
Andre navne:
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
|
oral, daily Truvada for HIV-negative participants
Andre navne:
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
Andre navne:
collection of semen from an HIV-negative man, followed by intravaginal insemination
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Uptake of safer conception strategies
Tidsramme: 12 months
|
proportion of couples choosing the strategy
|
12 months
|
Acceptability of safer conception strategies
Tidsramme: 12 months
|
proportion of couples remaining on strategy; reports of satisfaction
|
12 months
|
Adherence to safer conception strategies
Tidsramme: 12 months
|
proportion of couples with high adherence to strategy
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effectiveness of safer conception strategies on HIV prevention
Tidsramme: 12 months
|
incidence of HIV
|
12 months
|
Effectiveness of safer conception strategies on achieving pregnancy
Tidsramme: 12 months
|
incidence of pregnancy
|
12 months
|
costs of providing safer conception services
Tidsramme: 12 months
|
costs
|
12 months
|
cost-effectiveness of safer conception strategies
Tidsramme: 12 months
|
model the cost effectiveness of various combinations of safer conception strategies
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joelle M Brown, PhD, MPH, University of California, San Francisco
- Ledende efterforsker: Felix Mhlanga, MBChB, MMed, UZ-UCSF Collaborative Research Programme
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. marts 2017
Primær færdiggørelse (Faktiske)
3. juni 2019
Studieafslutning (Faktiske)
31. juli 2019
Datoer for studieregistrering
Først indsendt
7. februar 2017
Først indsendt, der opfyldte QC-kriterier
7. februar 2017
Først opslået (Skøn)
9. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- HIV-infektioner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Tenofovir
- Emtricitabin
- Emtricitabin, Tenofovir Disoproxil Fumarate Lægemiddelkombination
- Anti-retrovirale midler
Andre undersøgelses-id-numre
- A126763
- K01MH100994 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified data will be made available at the end of the study on an online repository.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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