Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States

Sybil G. Hosek, Raphael J. Landovitz, Bill Kapogiannis, George K. Siberry, Bret Rudy, Brandy Rutledge, Nancy Liu, D. Robert Harris, Kathleen Mulligan, Gregory Zimet, Kenneth H. Mayer, Peter Anderson, Jennifer J. Kiser, Michelle Lally, Jennifer Brothers, Kelly Bojan, Jim Rooney, Craig M. Wilson

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

IMPORTANCE: Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults. OBJECTIVE: To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM). DESIGN, SETTING, AND PARTICIPANTS: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP. EXPOSURES: All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks. MAIN OUTCOMES AND MEASURES: The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC. RESULTS: Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively. CONCLUSIONS AND RELEVANCE: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01769456.

Original languageEnglish (US)
Pages (from-to)1063-1071
Number of pages9
JournalJAMA Pediatrics
Volume171
Issue number11
DOIs
StatePublished - Nov 1 2017

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HIV
Adolescent Medicine
Safety
Risk-Taking
Tenofovir
Sexual Behavior
Acquired Immunodeficiency Syndrome
Protective Agents
HIV-2
Sexually Transmitted Diseases
Hispanic Americans
African Americans
Infection
Population
tenofovir diphosphate

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States. / Hosek, Sybil G.; Landovitz, Raphael J.; Kapogiannis, Bill; Siberry, George K.; Rudy, Bret; Rutledge, Brandy; Liu, Nancy; Harris, D. Robert; Mulligan, Kathleen; Zimet, Gregory; Mayer, Kenneth H.; Anderson, Peter; Kiser, Jennifer J.; Lally, Michelle; Brothers, Jennifer; Bojan, Kelly; Rooney, Jim; Wilson, Craig M.

In: JAMA Pediatrics, Vol. 171, No. 11, 01.11.2017, p. 1063-1071.

Research output: Contribution to journalArticle

Hosek, SG, Landovitz, RJ, Kapogiannis, B, Siberry, GK, Rudy, B, Rutledge, B, Liu, N, Harris, DR, Mulligan, K, Zimet, G, Mayer, KH, Anderson, P, Kiser, JJ, Lally, M, Brothers, J, Bojan, K, Rooney, J & Wilson, CM 2017, 'Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States', JAMA Pediatrics, vol. 171, no. 11, pp. 1063-1071. https://doi.org/10.1001/jamapediatrics.2017.2007
Hosek, Sybil G. ; Landovitz, Raphael J. ; Kapogiannis, Bill ; Siberry, George K. ; Rudy, Bret ; Rutledge, Brandy ; Liu, Nancy ; Harris, D. Robert ; Mulligan, Kathleen ; Zimet, Gregory ; Mayer, Kenneth H. ; Anderson, Peter ; Kiser, Jennifer J. ; Lally, Michelle ; Brothers, Jennifer ; Bojan, Kelly ; Rooney, Jim ; Wilson, Craig M. / Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States. In: JAMA Pediatrics. 2017 ; Vol. 171, No. 11. pp. 1063-1071.
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T1 - Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States

AU - Hosek, Sybil G.

AU - Landovitz, Raphael J.

AU - Kapogiannis, Bill

AU - Siberry, George K.

AU - Rudy, Bret

AU - Rutledge, Brandy

AU - Liu, Nancy

AU - Harris, D. Robert

AU - Mulligan, Kathleen

AU - Zimet, Gregory

AU - Mayer, Kenneth H.

AU - Anderson, Peter

AU - Kiser, Jennifer J.

AU - Lally, Michelle

AU - Brothers, Jennifer

AU - Bojan, Kelly

AU - Rooney, Jim

AU - Wilson, Craig M.

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N2 - IMPORTANCE: Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults. OBJECTIVE: To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM). DESIGN, SETTING, AND PARTICIPANTS: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP. EXPOSURES: All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks. MAIN OUTCOMES AND MEASURES: The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC. RESULTS: Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively. CONCLUSIONS AND RELEVANCE: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01769456.

AB - IMPORTANCE: Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults. OBJECTIVE: To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM). DESIGN, SETTING, AND PARTICIPANTS: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP. EXPOSURES: All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks. MAIN OUTCOMES AND MEASURES: The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC. RESULTS: Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively. CONCLUSIONS AND RELEVANCE: Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01769456.

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