
pmid: 38783534
pmc: PMC11116478
AbstractIntroductionHPTN 083 demonstrated the superiority of long‐acting cabotegravir (CAB‐LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre‐exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.MethodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non‐adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.ResultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study‐related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non‐judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection‐related anxiety, which abated with time and when given some measure of control (e.g. pre‐injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).ConclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non‐judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.
Male, 1117 Public Health and Health Services (for), Social Determinants of Health, Pyridines, Epidemiology, Economics, Health Disparities (rcdc), Social Sciences, HPTN 083‐02 Study Team, HIV Infections, FOS: Health sciences, Sociology, 1103 Clinical Sciences (for), Psychology, Emtricitabine, 32 Biomedical and Clinical Sciences (for-2020), Male (mesh), 42 Health Sciences (for-2020), Pyridines (mesh), Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Pre-exposure prophylaxis, Human immunodeficiency virus (HIV), Homosexuality, Social science, Health Disparities, Clinical trial, Interviews as Topic (mesh), Attendance, HIV/AIDS, Medicine, Public Health, Microbicides for sexually transmitted diseases, Infection, Social Psychology, Pyridones, Tenofovir (mesh), Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Trials and Supportive Activities (rcdc), HIV prevention, 610, Sexual and Gender Minorities (SGM/LGBT*), Diketopiperazines, HIV Infections (mesh), Brazil (mesh), Transgender Persons, Medication Adherence, Clinical Research, 615, 4206 Public Health (for-2020), Middle Aged (mesh), Health Sciences, Humans, Global Epidemiology of HIV and Drug Use, Syphilis, Tenofovir Disoproxil Fumarate Drug Combination, Tenofovir, pre-exposure prophylaxis, Economic growth, Pre-Exposure Prophylaxis (mesh), HIV/AIDS (rcdc), Prevention, 3202 Clinical sciences (for-2020), Anti-HIV Agents (mesh), Injections (mesh), Infectious Diseases (rcdc), 4202 Epidemiology (for-2020), injectable PrEP, Adult (mesh), Sexually Transmitted Infections, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Pre-Exposure Prophylaxis, Immunologic diseases. Allergy, Prevention (rcdc), Assessment of Medication Adherence (mesh), Tenofovir Disoproxil Fumarate Drug Combination (mesh), men who have sex with men, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing (hrcs-rac), Clinical Research (rcdc), Anal sex, Minority Health, Viral load, Internal medicine, Research Articles, Humans (mesh), Young Adult (mesh), 3 Good Health and Well Being (sdg), Sexual and Gender Minorities (SGM/LGBT*) (rcdc), injection drug users, Middle Aged, 4 Quality Education (sdg), Health services, Antiretroviral therapy, FOS: Sociology, FOS: Psychology, Infection (hrcs-hc), Men who have sex with men, Mental Health, Infectious Diseases, Environmental health, Minority Health (rcdc), Female, Behavioral and Social Science (rcdc), Brazil, Mental Health (rcdc), Adult, transgender women, Family medicine, Anti-HIV Agents, Population, Social Determinants of Health (rcdc), Injections, Interviews as Topic, Young Adult, Intersectionality in LGBTQ+ Mental Health, Qualitative research, Behavioral and Social Science, 1199 Other Medical and Health Sciences (for), Transgender women, Homosexuality, Male, 3202 Clinical Sciences (for-2020), pre‐exposure prophylaxis, Assessment of Medication Adherence, Adherence to Medication, Biomedical and Clinical Sciences, Prevention and Treatment of HIV/AIDS Infection, RC581-607, Diketopiperazines (mesh), Quality Education, Good Health and Well Being, Transgender Persons (mesh), Pyridones (mesh), 4206 Public health (for-2020), Female (mesh), qualitative, Sexually Transmitted Infections (rcdc)
Male, 1117 Public Health and Health Services (for), Social Determinants of Health, Pyridines, Epidemiology, Economics, Health Disparities (rcdc), Social Sciences, HPTN 083‐02 Study Team, HIV Infections, FOS: Health sciences, Sociology, 1103 Clinical Sciences (for), Psychology, Emtricitabine, 32 Biomedical and Clinical Sciences (for-2020), Male (mesh), 42 Health Sciences (for-2020), Pyridines (mesh), Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Pre-exposure prophylaxis, Human immunodeficiency virus (HIV), Homosexuality, Social science, Health Disparities, Clinical trial, Interviews as Topic (mesh), Attendance, HIV/AIDS, Medicine, Public Health, Microbicides for sexually transmitted diseases, Infection, Social Psychology, Pyridones, Tenofovir (mesh), Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Trials and Supportive Activities (rcdc), HIV prevention, 610, Sexual and Gender Minorities (SGM/LGBT*), Diketopiperazines, HIV Infections (mesh), Brazil (mesh), Transgender Persons, Medication Adherence, Clinical Research, 615, 4206 Public Health (for-2020), Middle Aged (mesh), Health Sciences, Humans, Global Epidemiology of HIV and Drug Use, Syphilis, Tenofovir Disoproxil Fumarate Drug Combination, Tenofovir, pre-exposure prophylaxis, Economic growth, Pre-Exposure Prophylaxis (mesh), HIV/AIDS (rcdc), Prevention, 3202 Clinical sciences (for-2020), Anti-HIV Agents (mesh), Injections (mesh), Infectious Diseases (rcdc), 4202 Epidemiology (for-2020), injectable PrEP, Adult (mesh), Sexually Transmitted Infections, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Pre-Exposure Prophylaxis, Immunologic diseases. Allergy, Prevention (rcdc), Assessment of Medication Adherence (mesh), Tenofovir Disoproxil Fumarate Drug Combination (mesh), men who have sex with men, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing (hrcs-rac), Clinical Research (rcdc), Anal sex, Minority Health, Viral load, Internal medicine, Research Articles, Humans (mesh), Young Adult (mesh), 3 Good Health and Well Being (sdg), Sexual and Gender Minorities (SGM/LGBT*) (rcdc), injection drug users, Middle Aged, 4 Quality Education (sdg), Health services, Antiretroviral therapy, FOS: Sociology, FOS: Psychology, Infection (hrcs-hc), Men who have sex with men, Mental Health, Infectious Diseases, Environmental health, Minority Health (rcdc), Female, Behavioral and Social Science (rcdc), Brazil, Mental Health (rcdc), Adult, transgender women, Family medicine, Anti-HIV Agents, Population, Social Determinants of Health (rcdc), Injections, Interviews as Topic, Young Adult, Intersectionality in LGBTQ+ Mental Health, Qualitative research, Behavioral and Social Science, 1199 Other Medical and Health Sciences (for), Transgender women, Homosexuality, Male, 3202 Clinical Sciences (for-2020), pre‐exposure prophylaxis, Assessment of Medication Adherence, Adherence to Medication, Biomedical and Clinical Sciences, Prevention and Treatment of HIV/AIDS Infection, RC581-607, Diketopiperazines (mesh), Quality Education, Good Health and Well Being, Transgender Persons (mesh), Pyridones (mesh), 4206 Public health (for-2020), Female (mesh), qualitative, Sexually Transmitted Infections (rcdc)
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 5 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Top 10% | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Top 10% |
