Periconception PrEP for HIV-exposed Ugandan Women
Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda.
To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits.
For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.
Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .
Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Mbarara, Uganda
- Mbarara University of Science and Technology
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Self Report Inclusion Criteria:
- Female
- Aged 18-35
- Likely to be fertile based on reproductive health history [55]
- Reported personal or partner desire to have a child in the next year [56-59]
- With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
- Live within 60km of clinic. Not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period
Objective Inclusion Criteria:
- HIV-negative (onsite rapid testing)
- Not currently pregnant (onsite urine b-hcg testing)
- Fluent in English or local language
- Otherwise able to participate in the informed consent process
Exclusion Criteria
- Currently pregnant
- HIV-positive
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: HIV-uninfected women
A sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship with a partner she reports as HIV-infected or likely to be HIV-infected (e.g.
taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP.
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Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month.
Maximum 19 month follow-up period (through pregnancy outcome).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Uptake of PrEP
Zeitfenster: 9 months
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Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception
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9 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Adherence to PrEP, daily pill taking behavior
Zeitfenster: 9 months
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We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement
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9 months
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Adherence to PrEP, plasma levels
Zeitfenster: 9 months
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We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=>40ng/mL).
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9 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2017P001853
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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