Inclusion or exclusion of cis and transgender women and gender non-conforming people in studies evaluating long-acting injectable therapy for the treatment and prevention of HIV: A protocol for a scoping review
Creators: name: Orkin, Chloe
name: Elias, Alexa Lita
Publisher: name: Open Science Framework
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: Social and Behavioral Sciences
subject: Sexual Health
subject: Gender non-conforming people
subject: Long-Acting Injectables
subject: Treatment
subject: PrEP
subject: ART
subject: HIV
subject: Transgender women
subject: Women's Health

description: LA-I Cabotegravir (CAB) and Rilpivirine (RPV) is a licensed NICE recommended complete regimen for treatment of HIV in people who are virologically suppressed and can provide sustained viral suppression for up to 3-6 months (1). In terms of HIV prevention, recent evidence from a range of cross-cultural settings demonstrates that 2-monthly injectable cabotegravir is safe and effective in preventing HIV for cisgender men and transgender women who have sex with men (2) , and superior to daily oral therapy for women (3). UNAIDS reports that 54% of the global population of people living with HIV are women and girls (4). Furthermore, transgender women have 66 times higher odds of contracting HIV than the general population, worldwide (5). These groups are heavily underrepresented in HIV research, which exacerbates gendered health inequities in people living with, or at risk of developing, HIV (6,7). We aim to further understand this evidence gap in the context of novel, long-acting injectable therapy for HIV. We will conduct a scoping review to investigate the extent to which women (cis &amp; trans) and GNCP are included in existing studies for LA-I therapy for HIV treatment and prevention. 1. Venkatesan P. Long-acting injectable ART for HIV: a (cautious) step forward. Lancet Microbe. 2022 Feb 1;3(2):e94. 2. Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595–608. 3. Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet. 2022 May 7;399(10337):1779–89. 4. Global HIV &amp; AIDS statistics — Fact sheet [Internet]. [cited 2023 Jul 4]. Available from: https://www.unaids.org/en/resources/fact-sheet 5. Stutterheim SE, Dijk M van, Wang H, Jonas KJ. The worldwide burden of HIV in transgender individuals: An updated systematic review and meta-analysis. PLOS ONE. 2021 Dec 1;16(12):e0260063. 6. KEY BARRIERS TO WOMEN’S ACCESS TO HIV TREATMENT: A GLOBAL REVIEW. UN Women; 2017 Dec. 7. Whelan I, Strachan S, Apea V, Orkin C, Paparini S. Barriers and facilitators to HIV pre-exposure prophylaxis for cisgender and transgender women in the UK. Lancet HIV [Internet]. 2023 Jun 1 [cited 2023 Jun 6];0(0). Available from: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(23)00080-2/fulltext 8. Curno MJ, Rossi S, Hodges-Mameletzis I, Johnston R. A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies. J Acquir Immune Deﬁc Syndr. 2016;71(2). 9. Wu Y ni, Yu H, Lu L, Li X, Liu X, Cao W, et al. Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol. BMJ Open. 2022 Dec 26;12(12):e063089.