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Partners Demonstration Project of PrEP and ART

7 dicembre 2017 aggiornato da: Jared Baeten, University of Washington

An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1013

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Kenya
      • Kisumu, Kenya
        • Kemri-Ucsf
      • Thika, Kenya
        • Partners in Prevention-Thika
  • Uganda
      • Bushenyi, Uganda
        • Kabwohe Clinical Research Center
      • Kampala, Uganda
        • Partners in Prevention-Infectious Diseases Institute LTD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

For couples

  • Risk score defining higher HIV-1 risk (≥6)
  • Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
  • Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
  • Did not participate in the Partners PrEP Study

For HIV-1 uninfected members of the couple (partner participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
  • Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance >60 mL/min
  • Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
  • Not currently pregnant or breastfeeding
  • Not currently enrolled in an HIV-1 prevention clinical trial
  • Not currently using PrEP
  • Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

For HIV-1 infected members of the couple (index participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
  • No history of WHO stage III or IV conditions
  • Not currently using ART
  • Not currently enrolled in an HIV-1 treatment study
  • Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Exclusion Criteria:

  • Otherwise not eligible based on the above inclusion criteria

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: PrEP as a bridge to ART
FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners
Droga: FTC-TDF PrEP
FTC-TDF PrEP for HIV-1 uninfected partners
Droga: ART
ART for HIV-1 infected partners

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
Lasso di tempo: 24 months
High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
Lasso di tempo: 24 months
High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
Lasso di tempo: 24 months
High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
Lasso di tempo: 24 months
Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
Lasso di tempo: 24 months
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods
24 months
PrEP initiation by HIV uninfected partners.
Lasso di tempo: 24 months

Measure the number of HIV-1 uninfected partners initiating PrEP.

Proportion of samples with detectable and quantifiable PrEP levels
24 months
PrEP adherence: Self-reported missed doses of PrEP.
Lasso di tempo: 24 months
Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP.
24 months
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
Lasso di tempo: 24 months
Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels.
24 months
PrEP adherence: PrEP hold.
Lasso di tempo: 24 months
Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue.
24 months
ART initiation.
Lasso di tempo: 24 months
Measure the number of HIV-1 infected partners initiating ART.
24 months
ART Adherence.
Lasso di tempo: 24 months
Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
Lasso di tempo: 24 months
Proportion of visits when participants report having sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
Lasso di tempo: 24 months
Proportion of visits when participants report having condomless sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
Lasso di tempo: 24 months
Proportion of visits when HIV-1 uninfected partners report outside partners.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
Lasso di tempo: 24 months
Proportion of couples in which the HIV-1 uninfected partner is female.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
Lasso di tempo: 24 months
Proportion of couples with desire to conceive a child.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
Lasso di tempo: 24 months
Number of couples continuing their relationship during follow up.
24 months
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
Lasso di tempo: 24 months
Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
Lasso di tempo: 24 months
Proportion of HIV-1 infected partners initiating ART.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
Lasso di tempo: 24 months
Proportion of partnership reporting to have children at baseline.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
Lasso di tempo: 24 months
Proportion of HIV infected partners with CD4 count >200, >350, >500.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
Lasso di tempo: 24 months
Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4.
24 months
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
Lasso di tempo: 24 months
We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation.
24 months
PrEP use and pregnancy: HIV-1 infection.
Lasso di tempo: 24 months
Number of HIV-1 infections among women who continue PrEP in pregnancy.
24 months
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
Lasso di tempo: 24 months
Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie.
24 months
PrEP use and pregnancy: Any serious adverse event.
Lasso di tempo: 24 months
Number of women who continue PrEP in pregnancy with any serious adverse event.
24 months
Infant growth for women who continue PrEP in pregnancy: Length.
Lasso di tempo: 24 months
Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Weight.
Lasso di tempo: 24 months
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Head circumference.
Lasso di tempo: 24 months
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Institute of Mental Health (NIMH)
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2012

Completamento primario (Effettivo)

1 giugno 2016

Completamento dello studio (Effettivo)

1 giugno 2016

Date di iscrizione allo studio

Primo inviato

10 maggio 2016

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2016

Primo Inserito (Stima)

18 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00001674
  • R01MH095507 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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