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Depression Among Pregnant and Breastfeeding Persons Participating in Two Randomized Trials of the Dapivirine Vaginal Ring and Oral Pre-Exposure Prophylaxis (PrEP) in Malawi, South Africa, Uganda, and Zimbabwe

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Abstract

Depression is associated with lower adherence to oral pre-exposure prophylaxis (PrEP) to prevent HIV, but data are not currently available on how depression may affect use of other HIV prevention methods including the dapivirine vaginal ring (DVR). We conducted a mixed methods study using data from the Microbicide Trials Network (MTN) 042/DELIVER (n = 558) and MTN-043/B-PROTECTED (n = 197) studies to describe the prevalence of depressive symptoms and explore how depressive symptoms may have influenced attitudes about use of the monthly DVR and once-daily oral PrEP tablet among pregnant and breastfeeding persons, respectively, in Malawi, South Africa, Uganda, and Zimbabwe. Eleven participants had high Edinburgh Postnatal Depression scores ≥ 10 in MTN-042/DELIVER (2%) and four participants (2%) in MTN-043/B-PROTECTED. In interviews with 9 participants who had high scores (6 DVR, 3 oral PrEP), those with depressive symptoms described overlapping stressors which were magnified by job loss and economic instability during the COVID-19 pandemic, and by experiences of pregnancy/postpartum. These participants experienced a lack of support from partners or family members, and conflict with partners related to trust, and infidelity. While we did not find evidence of a change in product adherence, there was a strong sense of commitment and motivation to use the study products for protection from HIV for participants themselves and their baby. Although lack of social support is usually an obstacle to adherence, in this study, the participants’ lives and relationships seemed to have reinforced the need for HIV prevention and motivated women to protect themselves and their babies from HIV.

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Data Availability

Data are available through the Microbicide Trials Network.

References

  1. Moodley D, Esterhuizen TM, Pather T, Chetty V, Ngaleka L. High HIV incidence during pregnancy: compelling reason for repeat HlV testing. AIDS. 2009.

  2. Gray RH, Li X, Kigozi G, Serwadda D, Brahmbhatt H, Wabwire-Mangen F et al. Increased risk of incident HIV during pregnancy in Rakai, Uganda: a prospective study. Lancet. 2005.

  3. Mofenson LM. Risk of HIV Acquisition during pregnancy and Postpartum: a call for action. J Infect Dis. 2018.

  4. Thomson KA, Hughes J, Baeten JM, John-Stewart G, Celum C, Cohen CR et al. Increased risk of HIV Acquisition among women throughout pregnancy and during the Postpartum period: a prospective per-coital-act analysis among women with HIV-Infected partners. J Infect Dis. 2018.

  5. Machekano R, Tiam A, Kassaye S, Tukei V, Gill M, Mohai F et al. HIV incidence among pregnant and postpartum women in a high prevalence setting. PLoS ONE. 2018.

  6. Drake AL, Wagner A, Richardson B, John-Stewart G. Incident HIV during pregnancy and Postpartum and Risk of Mother-to-child HIV Transmission: a systematic review and Meta-analysis. PLoS Med. 2014.

  7. Fisher J, de Mello MC, Patel V, Rahman A, Tran T, Holton S, et al. Prevalence and determinants of common perinatal mental disorders in women in low- and lower-middle-income countries: a systematic review. Bull World Health Organ. 2012;90:139.

    Article  Google Scholar 

  8. Hartley M, Tomlinson M, Greco E, Comulada WS, Stewart J, le Roux I, et al. Depressed mood in pregnancy: prevalence and correlates in two Cape Town peri-urban settlements. Reprod Health. 2011;8:9.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Manikkam L, Burns JK. Antenatal depression and its risk factors: an urban prevalence study in KwaZulu-Natal. S Afr Med J. 2012;102:940–4.

    Article  PubMed  Google Scholar 

  10. Chibanda D, Mangezi W, Tshimanga M, Woelk G, Rusakaniko S, Stranix-Chibanda L, et al. Postnatal depression by HIV status among women in Zimbabwe. J Womens Health (Larchmt). 2010;19:2071–7.

    Article  PubMed  Google Scholar 

  11. Rochat TJ, Richter LM, Doll HA, Buthelezi NP, Tomkins A, Stein A. Depression among pregnant rural South African women undergoing HIV Testing. JAMA. 2006;295:1373–8.

    Article  Google Scholar 

  12. Rochat TJ, Tomlinson M, Bärnighausen T, Newell ML, Stein A. The prevalence and clinical presentation of antenatal depression in rural South Africa. J Affect Disord. 2011;135:362–73.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Rochat TJ, Tomlinson M, Newell ML, Stein A. Detection of antenatal depression in rural HIV-affected populations with short and ultrashort versions of the Edinburgh postnatal depression scale (EPDS). Arch Womens Ment Health. 2013;16:401.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Tsai AC, Scott JA, Hung KJ, Zhu JQ, Matthews LT, Psaros C et al. Reliability and validity of instruments for assessing perinatal depression in African settings: systematic review and meta-analysis. PLoS ONE. 2013;8.

  15. Nyamukoho E, Mangezi W, Marimbe B, Verhey R, Chibanda D. Depression among HIV positive pregnant women in Zimbabwe: A primary health care based cross-sectional study. BMC Pregnancy Childbirth [Internet]. 2019 [cited 2022 Apr 7];19:1–7. Available from: https://bmcpregnancychildbirth.biomedcentral.com/articles/https://doi.org/10.1186/s12884-019-2193-y.

  16. Abebe W, Gebremariam M, Molla M, Teferra S, Wissow L, Ruff A. Prevalence of depression among HIV-positive pregnant women and its association with adherence to antiretroviral therapy in Addis Ababa, Ethiopia. PLoS ONE. 2022;17.

  17. Psaros C, Smit JA, Mosery N, Bennett K, Coleman JN, Bangsberg DR, et al. PMTCT adherence in pregnant South African women: the role of Depression, Social Support, Stigma, and structural barriers to Care. Ann Behav Med. 2020;54:626–36.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Psaros C, Stanton AM, Raggio GA, Mosery N, Goodman GR, Briggs ES et al. Optimizing PMTCT adherence by treating Depression in Perinatal Women with HIV in South Africa: a pilot randomized controlled trial. Int J Behav Med. 2022.

  19. Gonzalez JS, Batchelder AW, Psaros C, Safren SA. Depression and HIV/AIDS treatment nonadherence: A review and meta-analysis. J Acquir Immune Defic Syndr (1988). Lippincott Williams and Wilkins; 2011. p. 181–7.

  20. Uthman OA, Magidson JF, Safren SA, Nachega JB. Depression and adherence to antiretroviral therapy in low-, middle- and high-income countries: a systematic review and meta-analysis. Curr HIV/AIDS Rep. 2014;11:291.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, et al. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012;26:2039–52.

    Article  PubMed  Google Scholar 

  22. Velloza J, Hosek S, Donnell D, Anderson PL, Chirenje M, Mgodi N, et al. Assessing longitudinal patterns of depressive symptoms and the influence of symptom trajectories on HIV pre-exposure prophylaxis adherence among adolescent girls in the HPTN 082 randomized controlled trial. J Int AIDS Soc. 2021;24:e25731.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Velloza J, Baeten JM, Haberer J, Ngure K, Irungu E, Mugo NR, et al. Effect of depression on adherence to oral PrEP among men and women in East Africa. J Acquir Immune Defic Syndr (1988). 2018;79:330–8.

    Article  Google Scholar 

  24. WHO. WHO recommends the dapivirine. vaginal ring as a new choice for HIV prevention for women at substantial risk of HIV infection [Internet]. World Health Organization. 2021 [cited 2021 Nov 8]. Available from: https://www.who.int/news/item/26-01-2021-who-recommends-the-dapivirine-vaginal-ring-as-a-new-choice-for-hiv-prevention-for-women-at-substantial-risk-of-hiv-infection.

  25. The Health Times. #BREAKING: Dapivirine, Vaginal Ring Approved for Use in Zimbabwe - HealthTimes [Internet]. 2021 [cited 2021 Oct 7]. Available from: https://healthtimes.co.zw/2021/07/14/breaking-dapivirine-vaginal-ring-approved-for-use-in-zimbabwe/.

  26. Montgomery ET, Hawley I, Fairlie L, Bunge K, Mathebula F, Etima J et al. Acceptability of the dapivirine vaginal ring and oral Truvada among African users in late-stage of pregnancy. AIDS Behav. 2023;(in press).

  27. Stoner MCD, Hawley I, Mathebula F, Horne E, Etima J, Kemigisha D et al. Acceptability and Use of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) During Breastfeeding in South Africa, Malawi, Zimbabwe, and Uganda. AIDS Behav [Internet]. 2023 [cited 2023 Aug 1];1–10. Available from: https://link.springer.com/article/10.1007/s10461-023-04125-w.

  28. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression: development of the 10-item Edinburgh postnatal depression scale. Br J Psychiatry. 1987;150:782–6.

    Article  CAS  PubMed  Google Scholar 

  29. Wisner KL, Parry BL, Piontek CM. Postpartum Depression. N Engl J Med. 2002;347:194–9.

    Article  PubMed  Google Scholar 

  30. Shrestha SD, Pradhan R, Tran TD, Gualano RC, Fisher JRW. Reliability and validity of the Edinburgh postnatal depression scale (EPDS) for detecting perinatal common mental disorders (PCMDs) among women in low-and lower-middle-income countries: a systematic review. BMC Pregnancy Childbirth. 2016;16.

  31. Levis B, Negeri Z, Sun Y, Benedetti A, Thombs BD. Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: systematic review and meta-analysis of individual participant data. BMJ. 2020;371.

  32. Lawrie TA, Hofmeyr GJ, de Jager M, Berk M. Validation of the Edinburgh Postnatal Depression Scale on a cohort of South African women - PubMed. S Afr Med J. 1998;88:1340–4.

    CAS  PubMed  Google Scholar 

  33. Creswell JW, Plano-Clark VL. Choosing a mixed methods design. Designing and Conducting Mixed Method Research; 2011.

  34. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016.

  35. Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based Preexposure Prophylaxis for HIV infection among African women. N Engl J Med. 2015;372:509–18.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Katz AWK, Naidoo K, Reddy K, Chitukuta M, Nabukeera J, Siva S et al. The power of the Shared experience: MTN-020/ASPIRE trial participants’ descriptions of peer influence on acceptability of and adherence to the Dapivirine Vaginal Ring for HIV Prevention. AIDS Behav. 2020.

  38. Stoner MCD, Brown ER, Palanee-Phillips T, Mansoor LE, Tembo T, Nair G et al. The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence. AIDS Behav [Internet]. 2021 [cited 2023 Apr 20];25:4169–79. Available from: https://pubmed.ncbi.nlm.nih.gov/33939034/.

  39. Palanee-Phillips T, Roberts ST, Reddy K, Govender V, Naidoo L, Siva S et al. Impact of partner-related social harms on women’s adherence to the dapivirine vaginal ring during a phase III trial. J Acquir Immune Defic Syndr (1988). 2018.

  40. Montgomery CM, Lees S, Stadler J, Morar NS, Ssali A, Mwanza B et al. The role of partnership dynamics in determining the acceptability of condoms and microbicides. AIDS Care - Psychological and Socio-Medical Aspects of AIDS/HIV [Internet]. 2008 [cited 2021 May 18];20:733–40. Available from: https://pubmed.ncbi.nlm.nih.gov/18576176/.

  41. Montgomery ET, Van Der Straten A, Chidanyika A, Chipato T, Jaffar S, Padian N. The importance of male partner involvement for women’s acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe. AIDS Behav [Internet]. 2011 [cited 2021 May 18];15:959–69. Available from: https://pubmed.ncbi.nlm.nih.gov/20844946/.

  42. Montgomery ET, van der Straten A, Stadler J, Hartmann M, Magazi B, Mathebula F et al. Male Partner Influence on women’s HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the importance of understanding. AIDS Behav [Internet]. 2015 [cited 2021 May 18];19:784–93. Available from: /pmc/articles/PMC4416996/.

  43. Roberts ST, Nair G, Baeten JM, Palanee-Philips T, Schwartz K, Reddy K et al. Impact of Male Partner involvement on women’s adherence to the Dapivirine Vaginal Ring during a phase III HIV Prevention Trial. AIDS Behav. 2020.

  44. Ali GC, Ryan G, De Silva MJ. Validated Screening Tools for Common Mental disorders in Low and Middle Income countries: a systematic review. PLoS ONE. 2016;11.

  45. JE RU. Affective (depressive) morbidity in puerperal Nigerian women: validation of the Edinburgh postnatal depression scale. Acta Psychiatr Scand. 2003;107:251–9.

    Article  Google Scholar 

  46. Adewuya AO, Ola BA, Dada AO, Fasoto OO. Validation of the Edinburgh Postnatal Depression Scale as a screening tool for depression in late pregnancy among Nigerian women. J Psychosom Obstet Gynaecol. 2006;27:267–72.

    Article  PubMed  Google Scholar 

  47. Dinos S, Ascoli M, Owiti JA, Bhui K. Assessing explanatory models and health beliefs: an essential but overlooked competency for clinicians. BJPsych Adv. 2017;23:106–14.

    Article  Google Scholar 

  48. Desai G, Chaturvedi S. Idioms of distress. J Neurosci Rural Pract. 2017;8:S94.

    PubMed  PubMed Central  Google Scholar 

  49. Lasater ME, Beebe M, Warren NE, Souko F, Keita M, Murray SM, et al. Dusukasi—the heart that cries: an idiom of Mental Distress among Perinatal women in Rural Mali. Cult Med Psychiatry. 2018;42:930.

    Article  PubMed  PubMed Central  Google Scholar 

  50. Rao D, Young M, Raguram R. Culture, somatization, and psychological distress: symptom presentation in south Indian patients from a public psychiatric hospital. Psychopathology. 2007;40:349–55.

    Article  CAS  PubMed  Google Scholar 

  51. Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S et al. Effect of a primary care-based psychological intervention on symptoms of common mental disorders in Zimbabwe: a randomized clinical trial. JAMA - J Am Med Association. 2016.

  52. Remien RH, Patel V, Chibanda D, Abas MA. Integrating mental health into HIV prevention and care: a call to action. J Int AIDS Soc [Internet]. 2021 [cited 2021 Sep 26];24:e25748. Available from: https://onlinelibrary.wiley.com/doi/full/https://doi.org/10.1002/jia2.25748.

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Acknowledgements

Study Products: The dapivirine vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM). Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) was donated by Gilead Sciences.

Acknowledgement of the Full MTN-043/B-PROTECTED Study Team

Study Site Staff: Frank Taulo, MBBS, MPH, FCOG (Investigator of Record [IoR]), Linly Seyama, MSc, RNM (Study Coordinator [SC]), Zayithwa Fabiano, MBBS (SC), Sufia Dadabhai, PhD (Clinical Research Site [CRS] Leader), and Taha Taha, PhD (Clinical Trials Unit [CTU] Principal Investigator [PI], Johns Hopkins University Research Project; Brenda Gati Mirembe, MBChB, MSc (IoR), Phionah Bridget Kibalama Ssemambo, MBchB, MSc PH (SC), Clemensia Nakabiito, MBChB, MMed (Co-Investigator), and Mary Glenn Fowler, MD, MPH (CTU PI), Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration; Elizea Horne, MBChB (IoR), Carlotta Mabuza, BS, PGDip, Dip (SC), Lee Fairlie, MBChB, FCPaeds (CRS Leader), and Hermien Gous, PharmD (CRS Leader), Wits RHI Shandukani Research Centre; Felix Mhlanga, MBChB, MMed (IoR), Nyaradzo M. Mgodi, MBChB, Mmed, (IoR), Petina Musara, BSW (SC), and Z. Mike Chirenje, MD, FRCOG (CTU PI), University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC).

Protocol Team: Jeanna M. Piper, MD (DAIDS Senior Medical Officer (MO)), Naana Cleland, PhD, (Health Specialist Clinical Microbicide Research Branch (CMRB)), and Roberta Black, PhD (Chief, CMRB), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS); Nahida Chakhtoura, MD, MsGH (NICHD MO), Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH); Dianne M. Rausch, PhD, (Director, DAIDS Research) and Teri Senn, PhD (Program Chief, Psychosocial Comorbidities of HIV Prevention and Treatment), National Institutes of Mental Health (NIMH); James F. Rooney, MD (Vice President Medical Affairs), Gilead Sciences; Zeda Rosenberg, ScD (Chief Executive Officer), International Partnership for Microbicides; Craig Hendrix, MD, (Biomedical Science Working Group (BSWG) Representative, Protocol Pharmacologist), Jenny Robinson, MD, MPH, FACOG (BSWG Representative), Bonus Makanani MB BS, FCOG (SA), Department of Obstetrics & Gynecology, College of Medicine, University of Malawi, and College of Medicine-Johns Hopkins Research Project in Blantyre, Lisa Noguchi, PhD, CNM (Protocol Co-Chair), and Mark Marzinke, PhD, DABCC (Laboratory Center [LC] Pharmacology Core), Johns Hopkins University; Peter Anderson, PharmD (LC Pharmacology Core), University of Colorado School of Pharmacy; Rachel Scheckter, MPH (Sr. Clinical Research Manager [CRM]), Ashley J. Mayo, MPH (Sr. CRM), Tara McClure, MPH (Sr. CRM), Abraham Johnson, MPH (Community Program Associate), Cheryl Blanchette, MS(Sr. Community Program (MTN). Manager (CPM), Jontraye Davis, MHA (CPM), and Lisa Levy, MPH, MTN Associate Director, FHI 360; Katherine Bunge, MD, MPH (Protocol Safety Physician [PSP]), Richard H. Beigi, MD, MSc (Protocol Physician), and Sharon A. Riddler, MD, MPH (Protocol Physician), Magee-Womens Hospital and the University of Pittsburgh Medical Center (UPMC); Devika Singh, MD, MPH (PSP), University of Vermont; Cindy Jacobson, PharmD (Director of Pharmacy Affairs), Edward Livant, BSMT (ASCP), MPH (MTN LC Research Manager), May Beamer, BS (Laboratory Manager), Lisa Rossi, BA (MTN Director of Communications), Luis Duran, DrPH, MPIA, (Project Manager), Mei Song, PhD (Project Manager), and Sharon Hillier, PhD (MTN Principal Investigator), Magee-Womens Research Institute-UPMC; Elizabeth Montgomery, PhD (Behavioral Research Working Group [BRWG] Lead), Imogen Hawley, MA, MSc (Qualitative Coordinator), and Marie Stoner, PhD (Qualitative Coordinator), RTI International; Ivan Balan, PhD (BRWG Representative), Florida State University College of Medicine; Maxensia Owor, MBChB, MMed (Paed), MPH (Protocol Chair), MU-JHU; Barbra Richardson, PhD (Statistician), Jennifer Balkus, PhD, MPH (Protocol Co-Chair), Holly Gundacker, MS (Statistical Research Associate), Jillian Zemanek, MPH (Lead Clinical Data Manager), and Wen-Min Hou, MPH, BSN (Lead Clinical Safety Associate), Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center and the University of Washington.

Acknowledgement of the Full MTN-042/DELIVER Study Team:

Study Sites: Bonus Makanani†, MBBS, FCOG(SA) (Protocol Chair (PC), Investigator of Record (IoR)), Luis Gadama, MBBS, MMED UCT (IoR), Linly Seyama, Msc, RNM (Study Coordinator (SC)), Vitumbiko D. Mandiwa, MBBS (SC), Sufia Dadabhai, PhD (Clinical Research Site (CRS) Leader), and Taha E. Taha, PhD (Clinical Trials Unit Principal Investigator (CTU PI)), Johns Hopkins University (JHU) Research Project; Clemensia Nakabiito, MBChB, MMed (IoR), Phionah Bridget Kibalama Ssemambo, MBchB, MSc PH (SC), and Mary Glenn Fowler, MD, MPH (CTU PI), Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration; Lee Fairlie, MBChB, FCPaeds (Protocol Co-Chair, IoR), Carlotta Mabuza, BS, PGDip, Dip (SC), Hermien Gous, PharmD (CRS Leader), and Ringson Ngozo, DipEd (Community Working Group (CWG) Representative), Wits RHI Shandukani Research Centre; Felix Mhlanga, MBChB, MMed (PC), Nyaradzo M. Mgodi, MBChB, Mmed, (IoR), Petina Musara, BSW (SC) and Z. Mike Chirenje, MD, FRCOG (CTU PI), University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC).

Jeanna M. Piper, MD (DAIDS Senior Medical Officer (MO)), Naana Cleland, PhD, (Health Specialist Clinical Microbicide Research Branch (CMRB)), and Roberta Black, PhD (Chief, CMRB), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS); Nahida Chakhtoura, MD, MsGH (NICHD MO), Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH); Dianne M. Rausch, PhD, (Director, DAIDS Research) and Teri Senn, PhD (Program Chief, Psychosocial Co-morbidities of HIV Prevention and Treatment), National Institutes of Mental Health (NIMH); James F. Rooney, MD (Vice President Medical Affairs), Gilead Sciences; Zeda Rosenberg, ScD (Chief Executive Officer), International Partnership for Microbicides; Craig Hendrix, MD, (Biomedical Science Working Group (BSWG) Representative, Protocol Pharmacologist) and Mark Marzinke, PhD, DABCC (LC Pharmacology Core), Johns Hopkins University; Lisa Noguchi, PhD, CNM (Director, Pregnancy Research), Johns Hopkins Bloomberg School of Public Health; Peter Anderson, PharmD (LC Pharmacology Core), University of Colorado School of Pharmacy; Abraham Johnson, MPH (Community Program Associate), Ashley J. Mayo, MPH (Sr. Clinical Research Manager (CRM)), Cheryl Blanchette, MS(Sr. Community Program Manager (CPM), Jontraye Davis, MHA (CPM), Rachel Scheckter, MPH (Sr. CRM), Tara McClure, MPH (Sr. CRM), and Lisa Levy, MPH, MTN Associate Director, FHI 360; Katherine Bunge, MD, MPH (PC), Catherine A. Chappell, MD, MSc (Protocol Safety Physician (PSP)), Richard H. Beigi MD, MSc (Advisory), and Sharon A. Riddler, MD, MPH (Protocol Physician), Magee-Womens Hospital and the University of Pittsburg Medical Center (UPMC); Devika Singh, MD, MPH (PSP), Division of Infectious Diseases, University of Vermont; Cindy Jacobson, PharmD (Director of Pharmacy Affairs), Edward Livant, BSMT (ASCP), MPH (MTN LC Research Manager), Lisa Rossi, BA (MTN Director of Communications), Luis Duran, DrPH, MPIA, (Project Manager), Mei Song, PhD (Project Manager), and Sharon Hillier, PhD (MTN Principal Investigator), Magee-Womens Research Institute-UPMC; Ariana Katz, MPH (Behavioral Research Coordinator), Elizabeth Montgomery, PhD (BRWG Representative), Imogen Hawley, MA, MSc (Behavioral Research Coordinator), and Marie Stoner, PhD (Behavioral Co-Investigator), RTI International; Ariane van der Straten, PhD, MPH (Behavioral Research Working Group (BRWG) Representative), University of California San Francisco; Ivan Balan, PhD (BRWG Representative), Florida State University College of Medicine; Barbra Richardson, PhD (Statistician), Jennifer Balkus, PhD, MPH (Protocol Epidemiologist), Daniel Szydlo, MS, (Statistical Research Associate), Lena Kemel, Pharm.D. (Clinical Safety Associate), and Tanya Harrell, BS (Clinical Data Manager), Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center and the University of Washington.

†Deceased

MTN-042 Interim Review Panel Members: We would like to thank the members of the MTN-042 Interim Review Panel who donated their time to review safety data between study cohorts: Deborah M. Money, MD, FRCSC; Annie Lyerly, MD, MA; Richard Adanu, PhD; Professor Ellen Chirwa, PhD MRNM; Paige Williams, PhD, MS; Charles Shey Wiysonge, MD, PhD; Dorothy Mbori-Ngacha, MBChB, MMed, MPH.

Qualitative Staff:Blantyre Site Linly Seyama (qualitative Coordinator), Mirriam U. Mkandawire (interviewer), Abigail Mnemba (interviewer), Agness Kaumba (interviewer), Grace Kamthunzi (interviewer), Alinafe Kamanga (qualitative Data Officer). Uganda Site: Juliane Etima (qualitative lead) Doreen Kemigisha (Qualitative study coordinator), Josephine Nabukeera (interviewer), Joseph Ggita (transcriber/translator), Victor Snowball Guma (transcriber/translator), Carolyn Cheptora (qualitative personal). South Africa site: Charlotte Mabuza (study coordinator), Florence Mathebula (qualitative coordinator), Rebone Mohuba (interviewer), Luyanda Mavuya (research nurse), Mapebe Nhlapo (research nurse), Nokuthula Biyela (research nurse). Zimbabwe Site: Petina Musara (study coordinator), Prisca Mutero ( qualitative coordinator), Adlight Dandadzi (interviewer), Natasha Sedze (interviewer).

Data Management: Data management was provided by The Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Center, Seattle, WA) and site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA). For qualitative data, management was provided by the Women’s Global Health Imperative Program (RTI International, Berkeley, CA). We would also like to acknowledge Maryam Matean and Alejandro Baez at RTI international for their support with qualitative coding and analysis.

Funding

The study was designed and implemented by the Microbicide Trials Network (MTN). From 2006 until November 30, 2021, the MTN was an HIV/AIDS clinical trial network funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Author information

Authors and Affiliations

  1. RTI International, Berkeley, CA, USA

    Marie C.D. Stoner, Alinda Young & Elizabeth T. Montgomery

  2. Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda

    Juliane Etima

  3. Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe

    Natasha Sedze

  4. FHI 360, Durham , NC, USA

    Rachel Scheckter

  5. Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

    Florence Mathebula & Rebone Mohuba

  6. National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA

    Jeanna Piper

  7. ASTRA Consulting, Berkeley, CA, USA

    Ariane van der Straten

  8. Division of Reproductive, Maternal, Newborn, Child and Adolescent Health, Jhpiego/Johns Hopkins University, Washington, DC, USA

    Lisa Noguchi

  9. Johns Hopkins Project, Kamuzu University of Health Sciences, Blantyre, Malawi

    Linly Seyama & Zayithwa Fabiano

  10. Florida State University College of Medicine, Tallahassee, FL, USA

    Iván C. Balán

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  1. Marie C.D. Stoner
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Contributions

MCDS, AY and ETM managed qualitative data and did coding and data analysis. FM, NS, LS, RM, ZF, JE generated qualitative themes and did qualitative analysis. FM, NS, LS, RM, ZF, and JE conducted data collection, and quality control of transcripts. RS, AvS, JP, LN, LM, and IB over saw study implementation. MCDS led manuscript writing with support from AY, IB and ETM. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Marie C.D. Stoner.

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Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the following Institutional Review Boards/Ethics Committees and Drug Regulatory Authorities: Prevention Sciences Research Committee of the US National Institute of Allergy and Infectious Diseases; US Food and Drug Administration; College of Medicine Research and Ethics Committee; Johns Hopkins School of Public Health Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; South African Health Products Regulatory Authority; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins Medicine Office of Human Subjects Research Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe

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All participants provided informed consent for the study.

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Stoner, M.C., Mathebula, F., Sedze, N. et al. Depression Among Pregnant and Breastfeeding Persons Participating in Two Randomized Trials of the Dapivirine Vaginal Ring and Oral Pre-Exposure Prophylaxis (PrEP) in Malawi, South Africa, Uganda, and Zimbabwe. AIDS Behav (2024). https://doi.org/10.1007/s10461-024-04321-2

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