Comprehensive HIV Prevention Package for MSM in Port Elizabeth
4 juli 2017 uppdaterad av: Patrick S Sullivan, Emory University
The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in Africa.
Experience implementing the prevention interventions and preliminary data collected regarding the acceptability of the HIV prevention package will be used to develop a proposal to design a larger efficacy trial to test the combination HIV prevention package for MSM.
Studietyp
Interventionell
Inskrivning (Faktisk)
101
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Port Elizabeth, Sydafrika
- Human Sciences Research Council
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Male sex at birth
- Anal sex with another man in the past 12 months
- 18 years of age or older
- Resident of the study city, Port Elizabeth
- Able to complete study instruments, with or without assistance, in English, Xhosa or Afrikaans
- Willing to provide contact information
- Has a phone
Exclusion Criteria:
- Not male sex at birth
- No self-reported anal sex with a man in the past 12 months
- Less than 18 years of age
- Not a resident of the study city
- Plans to move from the study city within the year after enrollment
- Not able to complete study instructions, with or without assistance, in English, Xhosa or Afrikaans
- Not willing to provide contact information
- Does not have a phone
Additional Inclusion and Exclusion Criteria for participants on PrEP:
PrEP Inclusion Criteria:
- Identified as high-risk for HIV by the provider by meeting one or more of the criteria below:
- Have multiple partners
- Engage in transactional sex, including sex workers
- Use or abuse drugs
- Drink alcohol heavily
- Had more than 1 episode of a STI in the last year
- Is the HIV-negative partner in a discordant relationship, especially if the HIV-positive partner is not on antiretroviral therapy (ART)
- Is in a non-monogamous concordant relationship with a HIV-negative partner
- Is unable or unwilling to achieve consistent use of male condoms
- No contra-indications to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Calculated creatinine clearance of at least 60 mL/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN)
- Hepatitis B surface antigen (HBsAg) negative
- Motivated to follow PrEP prescribing guidelines
- Willing to adhere to daily oral dosing
- Willing to attend PrEP maintenance visits every 3 months
PrEP Exclusion Criteria:
- HIV positive
- Signs or symptoms suggestive of acute HIV infection
- Have baseline creatinine clearance <60 ml/min
- Are unwilling to follow PrEP prescribing guidelines
- Are unwilling to attend PrEP maintenance visits every 3 months
- Are known to have hypertensives or diabetes
- Are hepatitis B susceptible (test HBsAg and HBsAb negative) and refuse to take a hepatitis B vaccine series
- Any contraindication to taking FTC/TDF
- Proteinuria 2+ or greater at screening
- Glucosuria 2+ or greater at screening
- Use of antiretroviral (ARV) therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: HIV+ subjects
Men who test positive for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, risk-reduction counseling, couples HIV counseling and testing, and linkage to care
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Män kommer att få kondompaketet som inkluderar ett urval av stilar, storlekar, funktioner och färger vid deras baslinjebesök, och kommer att kunna få fler kondomer gratis när som helst efter det besöket genom att komma till en studieklinik under klinikens öppettider, eller under ett planerat studiebesök.
Män kommer att få kondomkompatibelt glidmedel som kommer att innehålla olika typer av smörjmedel (t.ex. silikonbaserat) och olika förpackningar (enskilda dospåsar eller platta, diskreta förpackningar) vid deras studiebesök, och deltagarna kommer att kunna få tillgång till förbättrad kondomkompatibel smörjmedel när som helst efter det besöket genom att komma till en studiemottagning under kliniktid eller under ett planerat studiebesök.
Deltagarna kommer att bjudas in att schemalägga par frivilliga HIV-rådgivning och testning (CVCT) möten med en klinikrådgivare när som helst efter att de avslutat sitt studiebesök.
Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services.
At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate.
Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.
Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit.
Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
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Experimentell: HIV- subjects
Men who test negative for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, enhanced HIV testing options, risk-reduction counseling, couples HIV counseling and testing, linkage to care, and screening for and offering of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). If men test positive for HIV during the study, they will be transitioned into the HIV+ subjects arm. |
Män kommer att få kondompaketet som inkluderar ett urval av stilar, storlekar, funktioner och färger vid deras baslinjebesök, och kommer att kunna få fler kondomer gratis när som helst efter det besöket genom att komma till en studieklinik under klinikens öppettider, eller under ett planerat studiebesök.
Män kommer att få kondomkompatibelt glidmedel som kommer att innehålla olika typer av smörjmedel (t.ex. silikonbaserat) och olika förpackningar (enskilda dospåsar eller platta, diskreta förpackningar) vid deras studiebesök, och deltagarna kommer att kunna få tillgång till förbättrad kondomkompatibel smörjmedel när som helst efter det besöket genom att komma till en studiemottagning under kliniktid eller under ett planerat studiebesök.
Deltagarna kommer att bjudas in att schemalägga par frivilliga HIV-rådgivning och testning (CVCT) möten med en klinikrådgivare när som helst efter att de avslutat sitt studiebesök.
Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services.
At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate.
Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.
Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit.
Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF). For men who meet eligibility criteria, Pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit.
Andra namn:
Rapid HIV testing at multiple time points
Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive.
They must be taken for 28 days.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Retention in the cohort
Tidsram: 12 months
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Will assess the ability of the study to retain participants for full study period.
This will be measured by the proportion of enrolled participants who attend all subsequent study visits through the 12-month visit.
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12 months
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Use of PrEP
Tidsram: 6 months
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Will assess uptake of PrEP by study participants.
This will be measured as the proportion of enrolled participants eligible for PrEP at the 3 and 6-month study visits who choose to initiate PrEP at those visits.
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6 months
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Incident HIV infection
Tidsram: 12 months
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This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Condom use
Tidsram: 3 months
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Measured as the proportion of anal intercourse that is protected by condoms in the prior 3 months as self-reported reported in the questionnaire at each study visit.
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3 months
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Lubricant use
Tidsram: 3 months
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Measured as the proportion of condom-protected anal intercourse in the prior for 3 months for which condom-compatible lubricant is used as self-reported in the questionnaire at each study visit.
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3 months
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VCT and CVCT uptake
Tidsram: 12 months
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Measured as the number of times participants report HIV testing in the study period as part of the study visits and outside study visits compared to the number of time participants reported HIV testing in the year prior at baseline.
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12 months
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Serodiscordant unprotected anal intercourse (UAI)
Tidsram: 3 months
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Measured as self-reported UAI in the last 3 months with a partner of positive or unknown HIV status as self-reported in the questionnaire at each study visit, pre- and post-intervention.
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3 months
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Acceptability of PEP
Tidsram: 12 months
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Measured as the proportion of men who report an eligible exposure who accept and initiate PEP.
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12 months
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MSM-specific provider training
Tidsram: 12 months
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Measured as the proportion of providers who are offered training who accept the training.
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12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Stefan Baral, MD, MPH, CCFP, Johns Hopkins Bloomberg School of Public Health
- Huvudutredare: Nancy Phaswanamafuya, PhD, Human Sciences Research Council
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 mars 2017
Studieregistreringsdatum
Först inskickad
18 maj 2015
Först inskickad som uppfyllde QC-kriterierna
18 maj 2015
Första postat (Uppskatta)
20 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 juli 2017
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00079727
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .