En simpel intervention for at øge persistensen på PrEP i MSM for at forbedre beslutningstagningen
Kognitive skævheders rolle i beslutningen om at anmode om, tilbyde, acceptere og fortsætte på PrEP fra en sundhedsudbyder og patientperspektiv (mænd, der har sex med mænd)
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).
This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.
Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02118
- Boston Univeristy School ofPublic Health, Global Health
-
-
-
-
Gauteng
-
Pretoria, Gauteng, Sydafrika
- The Aurum POP INN Clinic
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
- Initiating PrEP on the date of enrolment
- Access to a mobile phone
- Willing and able to provide written informed consent in English
Exclusion Criteria:
- PrEP status unknown
- Previous PrEP experience within the last year (12 months from enrolment)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention group
Participants randomized into this group will receive a behavioral economics informed intervention to improve persistence among amongst high risk men newly initiating PrEP in South Africa. |
A light touch, once off, low cost. lay counsellor led intervention, designed to focus decision making around HIV prevention addressing present bias, salience and over optimism. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. |
|
Ingen indgriben: Control group
Usual care for high risk men newly initiating PrEP in South Africa. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Target population recruitment (feasibility)
Tidsramme: 5 months
|
The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log. |
5 months
|
|
Fidelity to intervention
Tidsramme: 5 months
|
Percent of intervention interactions that are delivered in the first 3 months (Max interactions in 3 months = 2 visit reminders and 24 text messages (2 per week) = 26 total interactions). |
5 months
|
|
Acceptability by intervention participants
Tidsramme: 5 months
|
The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm. |
5 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PrEP persistence at 3 months
Tidsramme: 4 months
|
PrEP persistence is defined as having at least a specific number of months of PrEP dispensed after study enrolment. The outcome is determined at the subsequent month to allow for variable timing around return visits. For example persistence at 3 months is defined as having at least 90 days of PrEP dispensed by 4 months. |
4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lawrence C Long, PhD MCom, Boston University School of Public Health,Global Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- HIV-infektioner
Andre undersøgelses-id-numre
- H-45113
- 1K01MH119923-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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