Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study

Michael Martin, Suphak Vanichseni, Pravan Suntharasamai, Udomsak Sangkum, Philip A. Mock, Benjamaporn Chaipung, Dararat Worrajittanon, Manoj Leethochawalit, Sithisat Chiamwongpaet, Somyot Kittimunkong, Roman J. Gvetadze, Janet M. McNicholl, Lynn A. Paxton, Marcel Curlin, Timothy H. Holtz, Taraz Samandari, Kachit Choopanya

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Abstract

Background Results of the randomised, double-blind, placebo-controlled Bangkok Tenofovir Study (BTS) showed that taking tenofovir daily as pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 49% in people who inject drugs. In an extension to the trial, participants were offered 1 year of open-label tenofovir. We aimed to examine the demographic characteristics, drug use, and risk behaviours associated with participants' uptake of and adherence to PrEP. Methods In this observational, open-label extension of the BTS (NCT00119106), non-pregnant, non-breastfeeding, HIV-negative BTS participants, all of whom were current or previous injecting drug users at the time of enrolment in the BTS, were offered daily oral tenofovir (300 mg) for 1 year at 17 Bangkok Metropolitan Administration drug-treatment clinics. Participant demographics, drug use, and risk behaviours were assessed at baseline and every 3 months using an audio computer-assisted self-interview. HIV testing was done monthly and serum creatinine was assessed every 3 months. We used logistic regression to examine factors associated with the decision to take daily tenofovir as PrEP, the decision to return for at least one PrEP follow-up visit, and greater than 90% adherence to PrEP. Findings Between Aug 1, 2013, and Aug 31, 2014, 1348 (58%) of the 2306 surviving BTS participants returned to the clinics, 33 of whom were excluded because they had HIV (n=27) or grade 2–4 creatinine results (n=6). 798 (61%) of the 1315 eligible participants chose to start open-label PrEP and were followed up for a median of 335 days (IQR 0–364). 339 (42%) participants completed 12 months of follow-up; 220 (28%) did not return for any follow-up visits. Participants who were 30 years or older (odds ratio [OR] 1·8, 95% CI 1·4–2·2; p<0·0001), injected heroin (OR 1·5, 1·1–2·1; p=0·007), or had been in prison (OR 1·7, 1·3–2·1; p<0·0001) during the randomised trial were more likely to choose PrEP than were those without these characteristics. Participants who reported injecting heroin or being in prison during the 3 months before open-label enrolment were more likely to return for at least one open-label follow-up visit than those who did not report injecting heroin (OR 3·0, 95 % CI 1·3–7·3; p=0·01) or being in prison (OR 2·3, 1·4–3·7; p=0·0007). Participants who injected midazolam or were in prison during open-label follow-up were more likely to be greater than 90% adherent than were those who did not inject midazolam (OR 2·2, 95% CI 1·2–4·3; p=0·02) or were not in prison (OR 4·7, 3·1–7·2; p<0·0001). One participant tested positive for HIV, yielding an HIV incidence of 2·1 (95% CI 0·05–11·7) per 1000 person-years. No serious adverse events related to tenofovir use were reported. Interpretation More than 60% of returning, eligible BTS participants started PrEP, which indicates that a substantial proportion of PWID who are knowledgeable about PrEP might be interested in taking it. Participants who had injected heroin or been in prison were more likely to choose to take PrEP, suggesting that participants based their decision to take PrEP, at least in part, on their perceived risk of incident HIV infection. Funding US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.

Original languageEnglish (US)
Pages (from-to)e59-e66
JournalThe Lancet HIV
Volume4
Issue number2
DOIs
StatePublished - Feb 1 2017

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Tenofovir
HIV
Prisons
Pharmaceutical Preparations
Odds Ratio
Heroin
Midazolam
Risk-Taking
HIV Infections
Creatinine
Pre-Exposure Prophylaxis
Demography

ASJC Scopus subject areas

  • Epidemiology
  • Immunology
  • Infectious Diseases
  • Virology

Cite this

Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs : an observational, open-label extension of the Bangkok Tenofovir Study. / Martin, Michael; Vanichseni, Suphak; Suntharasamai, Pravan; Sangkum, Udomsak; Mock, Philip A.; Chaipung, Benjamaporn; Worrajittanon, Dararat; Leethochawalit, Manoj; Chiamwongpaet, Sithisat; Kittimunkong, Somyot; Gvetadze, Roman J.; McNicholl, Janet M.; Paxton, Lynn A.; Curlin, Marcel; Holtz, Timothy H.; Samandari, Taraz; Choopanya, Kachit.

In: The Lancet HIV, Vol. 4, No. 2, 01.02.2017, p. e59-e66.

Research output: Contribution to journalArticle

Martin, M, Vanichseni, S, Suntharasamai, P, Sangkum, U, Mock, PA, Chaipung, B, Worrajittanon, D, Leethochawalit, M, Chiamwongpaet, S, Kittimunkong, S, Gvetadze, RJ, McNicholl, JM, Paxton, LA, Curlin, M, Holtz, TH, Samandari, T & Choopanya, K 2017, 'Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study', The Lancet HIV, vol. 4, no. 2, pp. e59-e66. https://doi.org/10.1016/S2352-3018(16)30207-7
Martin, Michael ; Vanichseni, Suphak ; Suntharasamai, Pravan ; Sangkum, Udomsak ; Mock, Philip A. ; Chaipung, Benjamaporn ; Worrajittanon, Dararat ; Leethochawalit, Manoj ; Chiamwongpaet, Sithisat ; Kittimunkong, Somyot ; Gvetadze, Roman J. ; McNicholl, Janet M. ; Paxton, Lynn A. ; Curlin, Marcel ; Holtz, Timothy H. ; Samandari, Taraz ; Choopanya, Kachit. / Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs : an observational, open-label extension of the Bangkok Tenofovir Study. In: The Lancet HIV. 2017 ; Vol. 4, No. 2. pp. e59-e66.
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title = "Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study",
abstract = "Background Results of the randomised, double-blind, placebo-controlled Bangkok Tenofovir Study (BTS) showed that taking tenofovir daily as pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 49{\%} in people who inject drugs. In an extension to the trial, participants were offered 1 year of open-label tenofovir. We aimed to examine the demographic characteristics, drug use, and risk behaviours associated with participants' uptake of and adherence to PrEP. Methods In this observational, open-label extension of the BTS (NCT00119106), non-pregnant, non-breastfeeding, HIV-negative BTS participants, all of whom were current or previous injecting drug users at the time of enrolment in the BTS, were offered daily oral tenofovir (300 mg) for 1 year at 17 Bangkok Metropolitan Administration drug-treatment clinics. Participant demographics, drug use, and risk behaviours were assessed at baseline and every 3 months using an audio computer-assisted self-interview. HIV testing was done monthly and serum creatinine was assessed every 3 months. We used logistic regression to examine factors associated with the decision to take daily tenofovir as PrEP, the decision to return for at least one PrEP follow-up visit, and greater than 90{\%} adherence to PrEP. Findings Between Aug 1, 2013, and Aug 31, 2014, 1348 (58{\%}) of the 2306 surviving BTS participants returned to the clinics, 33 of whom were excluded because they had HIV (n=27) or grade 2–4 creatinine results (n=6). 798 (61{\%}) of the 1315 eligible participants chose to start open-label PrEP and were followed up for a median of 335 days (IQR 0–364). 339 (42{\%}) participants completed 12 months of follow-up; 220 (28{\%}) did not return for any follow-up visits. Participants who were 30 years or older (odds ratio [OR] 1·8, 95{\%} CI 1·4–2·2; p<0·0001), injected heroin (OR 1·5, 1·1–2·1; p=0·007), or had been in prison (OR 1·7, 1·3–2·1; p<0·0001) during the randomised trial were more likely to choose PrEP than were those without these characteristics. Participants who reported injecting heroin or being in prison during the 3 months before open-label enrolment were more likely to return for at least one open-label follow-up visit than those who did not report injecting heroin (OR 3·0, 95 {\%} CI 1·3–7·3; p=0·01) or being in prison (OR 2·3, 1·4–3·7; p=0·0007). Participants who injected midazolam or were in prison during open-label follow-up were more likely to be greater than 90{\%} adherent than were those who did not inject midazolam (OR 2·2, 95{\%} CI 1·2–4·3; p=0·02) or were not in prison (OR 4·7, 3·1–7·2; p<0·0001). One participant tested positive for HIV, yielding an HIV incidence of 2·1 (95{\%} CI 0·05–11·7) per 1000 person-years. No serious adverse events related to tenofovir use were reported. Interpretation More than 60{\%} of returning, eligible BTS participants started PrEP, which indicates that a substantial proportion of PWID who are knowledgeable about PrEP might be interested in taking it. Participants who had injected heroin or been in prison were more likely to choose to take PrEP, suggesting that participants based their decision to take PrEP, at least in part, on their perceived risk of incident HIV infection. Funding US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.",
author = "Michael Martin and Suphak Vanichseni and Pravan Suntharasamai and Udomsak Sangkum and Mock, {Philip A.} and Benjamaporn Chaipung and Dararat Worrajittanon and Manoj Leethochawalit and Sithisat Chiamwongpaet and Somyot Kittimunkong and Gvetadze, {Roman J.} and McNicholl, {Janet M.} and Paxton, {Lynn A.} and Marcel Curlin and Holtz, {Timothy H.} and Taraz Samandari and Kachit Choopanya",
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TY - JOUR

T1 - Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs

T2 - an observational, open-label extension of the Bangkok Tenofovir Study

AU - Martin, Michael

AU - Vanichseni, Suphak

AU - Suntharasamai, Pravan

AU - Sangkum, Udomsak

AU - Mock, Philip A.

AU - Chaipung, Benjamaporn

AU - Worrajittanon, Dararat

AU - Leethochawalit, Manoj

AU - Chiamwongpaet, Sithisat

AU - Kittimunkong, Somyot

AU - Gvetadze, Roman J.

AU - McNicholl, Janet M.

AU - Paxton, Lynn A.

AU - Curlin, Marcel

AU - Holtz, Timothy H.

AU - Samandari, Taraz

AU - Choopanya, Kachit

PY - 2017/2/1

Y1 - 2017/2/1

N2 - Background Results of the randomised, double-blind, placebo-controlled Bangkok Tenofovir Study (BTS) showed that taking tenofovir daily as pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 49% in people who inject drugs. In an extension to the trial, participants were offered 1 year of open-label tenofovir. We aimed to examine the demographic characteristics, drug use, and risk behaviours associated with participants' uptake of and adherence to PrEP. Methods In this observational, open-label extension of the BTS (NCT00119106), non-pregnant, non-breastfeeding, HIV-negative BTS participants, all of whom were current or previous injecting drug users at the time of enrolment in the BTS, were offered daily oral tenofovir (300 mg) for 1 year at 17 Bangkok Metropolitan Administration drug-treatment clinics. Participant demographics, drug use, and risk behaviours were assessed at baseline and every 3 months using an audio computer-assisted self-interview. HIV testing was done monthly and serum creatinine was assessed every 3 months. We used logistic regression to examine factors associated with the decision to take daily tenofovir as PrEP, the decision to return for at least one PrEP follow-up visit, and greater than 90% adherence to PrEP. Findings Between Aug 1, 2013, and Aug 31, 2014, 1348 (58%) of the 2306 surviving BTS participants returned to the clinics, 33 of whom were excluded because they had HIV (n=27) or grade 2–4 creatinine results (n=6). 798 (61%) of the 1315 eligible participants chose to start open-label PrEP and were followed up for a median of 335 days (IQR 0–364). 339 (42%) participants completed 12 months of follow-up; 220 (28%) did not return for any follow-up visits. Participants who were 30 years or older (odds ratio [OR] 1·8, 95% CI 1·4–2·2; p<0·0001), injected heroin (OR 1·5, 1·1–2·1; p=0·007), or had been in prison (OR 1·7, 1·3–2·1; p<0·0001) during the randomised trial were more likely to choose PrEP than were those without these characteristics. Participants who reported injecting heroin or being in prison during the 3 months before open-label enrolment were more likely to return for at least one open-label follow-up visit than those who did not report injecting heroin (OR 3·0, 95 % CI 1·3–7·3; p=0·01) or being in prison (OR 2·3, 1·4–3·7; p=0·0007). Participants who injected midazolam or were in prison during open-label follow-up were more likely to be greater than 90% adherent than were those who did not inject midazolam (OR 2·2, 95% CI 1·2–4·3; p=0·02) or were not in prison (OR 4·7, 3·1–7·2; p<0·0001). One participant tested positive for HIV, yielding an HIV incidence of 2·1 (95% CI 0·05–11·7) per 1000 person-years. No serious adverse events related to tenofovir use were reported. Interpretation More than 60% of returning, eligible BTS participants started PrEP, which indicates that a substantial proportion of PWID who are knowledgeable about PrEP might be interested in taking it. Participants who had injected heroin or been in prison were more likely to choose to take PrEP, suggesting that participants based their decision to take PrEP, at least in part, on their perceived risk of incident HIV infection. Funding US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.

AB - Background Results of the randomised, double-blind, placebo-controlled Bangkok Tenofovir Study (BTS) showed that taking tenofovir daily as pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 49% in people who inject drugs. In an extension to the trial, participants were offered 1 year of open-label tenofovir. We aimed to examine the demographic characteristics, drug use, and risk behaviours associated with participants' uptake of and adherence to PrEP. Methods In this observational, open-label extension of the BTS (NCT00119106), non-pregnant, non-breastfeeding, HIV-negative BTS participants, all of whom were current or previous injecting drug users at the time of enrolment in the BTS, were offered daily oral tenofovir (300 mg) for 1 year at 17 Bangkok Metropolitan Administration drug-treatment clinics. Participant demographics, drug use, and risk behaviours were assessed at baseline and every 3 months using an audio computer-assisted self-interview. HIV testing was done monthly and serum creatinine was assessed every 3 months. We used logistic regression to examine factors associated with the decision to take daily tenofovir as PrEP, the decision to return for at least one PrEP follow-up visit, and greater than 90% adherence to PrEP. Findings Between Aug 1, 2013, and Aug 31, 2014, 1348 (58%) of the 2306 surviving BTS participants returned to the clinics, 33 of whom were excluded because they had HIV (n=27) or grade 2–4 creatinine results (n=6). 798 (61%) of the 1315 eligible participants chose to start open-label PrEP and were followed up for a median of 335 days (IQR 0–364). 339 (42%) participants completed 12 months of follow-up; 220 (28%) did not return for any follow-up visits. Participants who were 30 years or older (odds ratio [OR] 1·8, 95% CI 1·4–2·2; p<0·0001), injected heroin (OR 1·5, 1·1–2·1; p=0·007), or had been in prison (OR 1·7, 1·3–2·1; p<0·0001) during the randomised trial were more likely to choose PrEP than were those without these characteristics. Participants who reported injecting heroin or being in prison during the 3 months before open-label enrolment were more likely to return for at least one open-label follow-up visit than those who did not report injecting heroin (OR 3·0, 95 % CI 1·3–7·3; p=0·01) or being in prison (OR 2·3, 1·4–3·7; p=0·0007). Participants who injected midazolam or were in prison during open-label follow-up were more likely to be greater than 90% adherent than were those who did not inject midazolam (OR 2·2, 95% CI 1·2–4·3; p=0·02) or were not in prison (OR 4·7, 3·1–7·2; p<0·0001). One participant tested positive for HIV, yielding an HIV incidence of 2·1 (95% CI 0·05–11·7) per 1000 person-years. No serious adverse events related to tenofovir use were reported. Interpretation More than 60% of returning, eligible BTS participants started PrEP, which indicates that a substantial proportion of PWID who are knowledgeable about PrEP might be interested in taking it. Participants who had injected heroin or been in prison were more likely to choose to take PrEP, suggesting that participants based their decision to take PrEP, at least in part, on their perceived risk of incident HIV infection. Funding US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.

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