Clinical trial NCT06133686 - References

HIV — Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Citation(s)

•   Abstracts from the 2022 Conference on Retroviruses and Opportunistic Infections
  Top Antivir Med. 2022 Mar;30(1s):3-382. No abstract available.
•   Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, Biello KB, Roth AM, Strathdee SA, Pines HA
  Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California. AIDS Patient Care STDS. 2022 Jul;36(7):254-262. doi: 10.1089/apc.2022.0068. Epub 2022 Jun 21.
•   Birgisson NE, Zhao Q, Secura GM, Madden T, Peipert JF
  Preventing Unintended Pregnancy: The Contraceptive CHOICE Project in Review. J Womens Health (Larchmt). 2015 May;24(5):349-53. doi: 10.1089/jwh.2015.5191. Epub 2015 Mar 31.
•   Breitenstein SM, Gross D, Garvey CA, Hill C, Fogg L, Resnick B
  Implementation fidelity in community-based interventions. Res Nurs Health. 2010 Apr;33(2):164-73. doi: 10.1002/nur.20373.
•   Cooper SE, Rosenblatt J, Gulick RM
  Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of Human Immunodeficiency Virus (HIV) in High-Income Countries. Clin Infect Dis. 2022 Nov 21;75(Suppl 4):S541-S548. doi: 10.1093/cid/ciac716.
•   Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC; HPTN 084 study group
  Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022 May 7;399(10337):1779-1789. doi: 10.1016/S0140-6736(22)00538-4. Epub 2022 Apr 1. Erratum In: Lancet. 2022 May 7;399(10337):1778.
•   Dietrich JJ, Ahmed N, Webb EL, Tshabalala G, Hornschuh S, Mulaudzi M, Atujuna M, Stranix-Chibanda L, Nematadzira T, Ssemata AS, Muhumuza R, Seeley J, Bekker LG, Weiss HA, Martinson N, Fox J; CHAPS team
  A multi-country cross-sectional study to assess predictors of daily versus on-demand oral pre-exposure prophylaxis in youth from South Africa, Uganda and Zimbabwe. J Int AIDS Soc. 2022 Aug;25(8):e25975. doi: 10.1002/jia2.25975.
•   Giguere K, Eaton JW, Marsh K, Johnson LF, Johnson CC, Ehui E, Jahn A, Wanyeki I, Mbofana F, Bakiono F, Mahy M, Maheu-Giroux M
  Trends in knowledge of HIV status and efficiency of HIV testing services in sub-Saharan Africa, 2000-20: a modelling study using survey and HIV testing programme data. Lancet HIV. 2021 May;8(5):e284-e293. doi: 10.1016/S2352-3018(20)30315-5. Epub 2021 Mar 2.
•   Gill K, Johnson L, Dietrich J, Myer L, Marcus R, Wallace M, Pidwell T, Mendel E, Fynn L, Jones K, Wiesner L, Slack C, Strode A, Spiegel H, Hosek S, Rooney J, Gray G, Bekker LG
  Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. Lancet Child Adolesc Health. 2020 Dec;4(12):875-883. doi: 10.1016/S2352-4642(20)30248-0. Epub 2020 Oct 24.
•   Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA
  RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
•   Global Data Lab
  Subnational Human Development Index - South Africa. Global Data Lab. Available from: https://globaldatalab.org/shdi/shdi/ZAF/ (Accessed July 1, 2023).
•   Guidelines on Long-Acting Injectable Cabotegravir for HIV Prevention [Internet]
  Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK586584/
•   Iwuji CC, Orne-Gliemann J, Larmarange J, Balestre E, Thiebaut R, Tanser F, Okesola N, Makowa T, Dreyer J, Herbst K, McGrath N, Barnighausen T, Boyer S, De Oliveira T, Rekacewicz C, Bazin B, Newell ML, Pillay D, Dabis F; ANRS 12249 TasP Study Group
  Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. Lancet HIV. 2018 Mar;5(3):e116-e125. doi: 10.1016/S2352-3018(17)30205-9. Epub 2017 Nov 30.
•   Jamieson L, Johnson LF, Nichols BE, Delany-Moretlwe S, Hosseinipour MC, Russell C, Meyer-Rath G
  Relative cost-effectiveness of long-acting injectable cabotegravir versus oral pre-exposure prophylaxis in South Africa based on the HPTN 083 and HPTN 084 trials: a modelled economic evaluation and threshold analysis. Lancet HIV. 2022 Dec;9(12):e857-e867. doi: 10.1016/S2352-3018(22)00251-X. Epub 2022 Nov 7.
•   Johnson L, Dorrington R
  Thembisa version 4.6: National and Provincial Model Outputs. Thembisa. 2023. Available from: https://www.thembisa.org/content/downloadPage/ProvOutput4_6 (Accessed July 4, 2023).
•   Johnson LF, Dorrington RE, Moolla H
  Progress towards the 2020 targets for HIV diagnosis and antiretroviral treatment in South Africa. South Afr J HIV Med. 2017 Jul 27;18(1):694. doi: 10.4102/sajhivmed.v18i1.694. eCollection 2017.
•   Kaewpoowat Q, Chariyalertsak S, Phanuphak N, Ramautarsing RA
  Long-acting preexposure prophylaxis in low- and middle-income countries: key considerations for implementation. Curr Opin HIV AIDS. 2022 May 1;17(3):135-144. doi: 10.1097/COH.0000000000000729. Epub 2022 Mar 4.
•   King DK, Glasgow RE, Leeman-Castillo B
  Reaiming RE-AIM: using the model to plan, implement, and evaluate the effects of environmental change approaches to enhancing population health. Am J Public Health. 2010 Nov;100(11):2076-84. doi: 10.2105/AJPH.2009.190959. Epub 2010 Sep 23.
•   Koss CA, Ayieko J, Mwangwa F, Owaraganise A, Kwarisiima D, Balzer LB, Plenty A, Sang N, Kabami J, Ruel TD, Black D, Camlin CS, Cohen CR, Bukusi EA, Clark TD, Charlebois ED, Petersen ML, Kamya MR, Havlir DV; SEARCH Collaboration
  Early Adopters of Human Immunodeficiency Virus Preexposure Prophylaxis in a Population-based Combination Prevention Study in Rural Kenya and Uganda. Clin Infect Dis. 2018 Nov 28;67(12):1853-1860. doi: 10.1093/cid/ciy390.
•   McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON
  Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 2;387(10013):53-60. doi: 10.1016/S0140-6736(15)00056-2. Epub 2015 Sep 9.
•   Mhlongo S, Dietrich J, Otwombe KN, Robertson G, Coates TJ, Gray G
  Factors associated with not testing for HIV and consistent condom use among men in Soweto, South Africa. PLoS One. 2013 May 16;8(5):e62637. doi: 10.1371/journal.pone.0062637. Print 2013.
•   Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group
  On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
•   Nglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker LG
  An incentivized HIV counseling and testing program targeting hard-to-reach unemployed men in Cape Town, South Africa. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):e28-34. doi: 10.1097/QAI.0b013e31824445f0.
•   Otwombe K, Dietrich J, Laher F, Hornschuh S, Nkala B, Chimoyi L, Kaida A, Gray GE, Miller CL
  Health-seeking behaviours by gender among adolescents in Soweto, South Africa. Glob Health Action. 2015 Feb 2;8:25670. doi: 10.3402/gha.v8.25670. eCollection 2015.
•   Parikh UM, Mellors JW
  How could HIV-1 drug resistance impact preexposure prophylaxis for HIV prevention? Curr Opin HIV AIDS. 2022 Jul 1;17(4):213-221. doi: 10.1097/COH.0000000000000746.
•   Philbin MM, Parish C, Kinnard EN, Reed SE, Kerrigan D, Alcaide ML, Cohen MH, Sosanya O, Sheth AN, Adimora AA, Cocohoba J, Goparaju L, Golub ET, Fischl M, Metsch LR
  Interest in Long-Acting Injectable Pre-exposure Prophylaxis (LAI PrEP) Among Women in the Women's Interagency HIV Study (WIHS): A Qualitative Study Across Six Cities in the United States. AIDS Behav. 2021 Mar;25(3):667-678. doi: 10.1007/s10461-020-03023-9.
•   Pike C, Bekker LG
  Interrogating the promise of long-acting HIV pre-exposure prophylaxis. Trends Mol Med. 2023 Feb;29(2):93-98. doi: 10.1016/j.molmed.2022.11.003. Epub 2022 Nov 23.
•   Pilgrim N, Jani N, Mathur S, Kahabuka C, Saria V, Makyao N, Apicella L, Pulerwitz J
  Provider perspectives on PrEP for adolescent girls and young women in Tanzania: The role of provider biases and quality of care. PLoS One. 2018 Apr 27;13(4):e0196280. doi: 10.1371/journal.pone.0196280. eCollection 2018.
•   Pilgrim NA, Evans TM, Czarnogorski M
  A Layer Plus Approach to Implementation Research and Collaboration for Long-Acting Injectable Preexposure Prophylaxis for HIV Prevention. Health Promot Pract. 2022 Nov;23(6):912-915. doi: 10.1177/15248399211053584. Epub 2022 Jun 17.
•   Pleuhs B, Quinn KG, Walsh JL, Petroll AE, John SA
  Health Care Provider Barriers to HIV Pre-Exposure Prophylaxis in the United States: A Systematic Review. AIDS Patient Care STDS. 2020 Mar;34(3):111-123. doi: 10.1089/apc.2019.0189. Epub 2020 Feb 28.
•   Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE
  A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
•   Proctor EK, Powell BJ, McMillen JC
  Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.
•   Quaife M, Cabrera M, Eakle R, Vickerman P, Delany-Moretlwe S, Terris-Prestholt F, editors
  One size will not fit all: divergent stated preferences for new antiretroviral-based HIV prevention products across adults, adolescents and female sex workers in South Africa. EUHEA Conference: Hamburg, Germany; 2016.
•   Quaife M, Eakle R, Cabrera Escobar MA, Vickerman P, Kilbourne-Brook M, Mvundura M, Delany-Moretlwe S, Terris-Prestholt F
  Divergent Preferences for HIV Prevention: A Discrete Choice Experiment for Multipurpose HIV Prevention Products in South Africa. Med Decis Making. 2018 Jan;38(1):120-133. doi: 10.1177/0272989X17729376. Epub 2017 Sep 1.
•   Shah S, Hindley L, Hill A
  Are New Antiretroviral Treatments Increasing the Risk of Weight Gain? Drugs. 2021 Feb;81(3):299-315. doi: 10.1007/s40265-020-01457-y.
•   Simbayi L, Zuma K, Zungu N, Moyo S, Marinda E, Jooste S, Mabaso M, Ramlangan S, North A, van Zyl J, Mohlabane N, Dietrich C, Naidoo I, SABSSM V Team
  South African national HIV prevalence, incidence, behaviour and communication survey, 2017: towards achieving the UNAIDS 90-90-90 targets [Internet]. 2019 [cited 2021 Apr 4]. Available from: http://repository.hsrc.ac.za/handle/20.500.11910/15052
•   Smith P, Marcus R, Bennie T, Nkala B, Nchabeleng M, Latka MH, Gray G, Wallace M, Bekker LG
  What do South African adolescents want in a sexual health service? Evidence from the South African Studies on HIV in Adolescents (SASHA) project. S Afr Med J. 2018 Jul 25;108(8):677-681. doi: 10.7196/SAMJ.2018.v108i8.13013.
•   Smith P, Tolla T, Marcus R, Bekker LG
  Mobile sexual health services for adolescents: investigating the acceptability of youth-directed mobile clinic services in Cape Town, South Africa. BMC Health Serv Res. 2019 Aug 19;19(1):584. doi: 10.1186/s12913-019-4423-4.
•   Smits J, Permanyer I
  The Subnational Human Development Database. Sci Data. 2019 Mar 12;6:190038. doi: 10.1038/sdata.2019.38.
•   Sued O, Nardi N, Spadaccini L
  Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Curr Opin HIV AIDS. 2022 May 1;17(3):145-161. doi: 10.1097/COH.0000000000000734. Epub 2022 Apr 18.
•   Suite DH, La Bril R, Primm A, Harrison-Ross P
  Beyond misdiagnosis, misunderstanding and mistrust: relevance of the historical perspective in the medical and mental health treatment of people of color. J Natl Med Assoc. 2007 Aug;99(8):879-85.
•   The Global Men and HIV Technical Working Group (MENHT)
  HIV gap in men. HIV gap in men: the Global Men and HIV Technical Working Group (MENHT) Webinar Series - Episode #4 (who.int) 2021.
•   World Health Organization : Differentiated and simplified pre-exposure prophylaxis for HIV prevention: update to WHO implementation guidance
  Technical Brief. Geneva: World Health Organization; 2022. Licence: CC BY.
•   Zhang J, Li C, Xu J, Hu Z, Rutstein SE, Tucker JD, Ong JJ, Jiang Y, Geng W, Wright ST, Cohen MS, Shang H, Tang W
  Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Lancet HIV. 2022 Apr;9(4):e254-e268. doi: 10.1016/S2352-3018(22)00030-3.

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa: a Phase 3b, Open-label, Hybrid Type 2 Implementation and Effectiveness Trial

Details for clinical trial NCT06133686