All Title Author
Keywords Abstract

PLOS ONE  2013 

Pregnancy in HIV Clinical Trials in Sub Saharan Africa: Failure of Consent or Contraception?

DOI: 10.1371/journal.pone.0073556

Full-Text   Cite this paper   Add to My Lib


Objective Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa. Methods Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP); and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO). 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use. Results All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel) would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.


[1]  Guengant J-P, May JF (2001) Impact of the proximate determinants on the future course of fertility in Sub-Saharan Africa. UN/POP/PFD/2001/3. Available: Accessed 2013 Aug 2.
[2]  UNFPA (2009) UNFPA Uganda Reproductive Health. Available: http://countryofficeunfpaorg/uganda/2009?/09/10/1283/information/. Accessed 2013 Aug 5.
[3]  Khan S, Bradley SEK, Fishel J, Mishra V (2008) Unmet Need and the Demand for Family Planning in Uganda. Further Analysis of the Uganda Demographic and Health Surveys, 1995–2006. USAID Report. Available: Accessed 2013 Aug 5.
[4]  Myer L, Carter RJ, Katyal M, Toro P, El-Sadr WM, et al. (2010) Impact of antiretroviral therapy on incidence of pregnancy among HIV-infected women in Sub-Saharan Africa: a cohort study. PLoS Med 7: e1000229.
[5]  Nakayiwa S, Abang B, Packel L, Lifshay J, Purcell DW, et al. (2006) Desire for children and pregnancy risk behavior among HIV-infected men and women in Uganda. AIDS Behav 10: S95–104.
[6]  Beyeza-Kashesya J, Ekstrom AM, Kaharuza F, Mirembe F, Neema S, et al. (2010) My partner wants a child: a cross-sectional study of the determinants of the desire for children among mutually disclosed sero-discordant couples receiving care in Uganda. BMC Public Health 10: 247.
[7]  Homsy J, Bunnell R, Moore D, King R, Malamba S, et al. (2009) Reproductive intentions and outcomes among women on antiretroviral therapy in rural Uganda: a prospective cohort study. PLoS One 4: e4149.
[8]  Grabbe K, Stephenson R, Vwalika B, Ahmed Y, Vwalika C, et al. (2009) Knowledge, use, and concerns about contraceptive methods among sero-discordant couples in Rwanda and Zambia. J Womens Health (Larchmt) 18: 1449–1456.
[9]  UNAIDS (2000) UNAIDS Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials – Report. Available: wwwunaidsorg/en/media/unaids/contentasse?ts//irc/una00-36_enpdf.Accessed 2013 Aug 5.
[10]  UNAIDS (2000) Ethical Considerations in HIV Preventive Vaccine Research, UNAIDS guidance document. Available: http://dataunaidsorg/publications/IRC-pu?b01/jc072-ethicalcons_enpdf. Accessed 2013 Aug 5.
[11]  Tolley E (2006) Ethical issues related to pregnancy during microbicide trials. Microbicides 2006 Conference, Cape Town Invited lecture.
[12]  Ramjee G, Wand H (2012) Population-level impact of hormonal contraception on incidence of HIV infection and pregnancy in women in Durban, South Africa. Bull World Health Organ 90: 748–755.
[13]  Rountree W (2006) Change in sexual behaviour post-pregnancy in the Savvy Ghana trial. Microbicides 2006 Conference, Cape Town,: Abstract OB17.
[14]  Parkes-Ratanshi R, Wakeham K, Levin J, Namusoke D, Whitworth J, et al. (2011) Primary prophylaxis of cryptococcal disease with fluconazole in HIV-positive Ugandan adults: a double-blind, randomised, placebo-controlled trial. Lancet Infect Dis 11: 933–941.
[15]  Microbicides Development, Programme (2009) MDP 301 Protocol. Available: http://wwwmdpmrcacuk/publications_docume?nts/MDP301_20_130208pdf. Accessed 2012 Oct 16.
[16]  Makumbi FE, Nakigozi G, Reynolds SJ, Ndyanabo A, Lutalo T, et al. (2011) Associations between HIV Antiretroviral Therapy and the Prevalence and Incidence of Pregnancy in Rakai, Uganda. AIDS Res Treat 2011: 519492.
[17]  Schreiber CA, Sammel M, Hillier SL, Barnhart KT (2009) A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials. Am J Epidemiol 169: 515–521.
[18]  Schreiber CA (2006) The impact of pregnancy on microbicide clinical trials. . Microbicides 2006 Conference, Cape Town PB67.
[19]  Sahin-Hodoglugil NN, Montgomery E, Kacanek D, Morar N, Mtetwa S, et al. (2011) User experiences and acceptability attributes of the diaphragm and lubricant gel in an HIV prevention trial in southern Africa. AIDS Care 23: 1026–1034.
[20]  van der Straten A, Kang MS, Posner SF, Kamba M, Chipato T, et al. (2005) Predictors of diaphragm use as a potential sexually transmitted disease/HIV prevention method in Zimbabwe. Sex Transm Dis 32: 64–71.
[21]  Lindegger G, Milford C, Slack C, Quayle M, Xaba X, et al. (2006) Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa. J Acquir Immune Defic Syndr 43: 560–566.
[22]  Colfax G, Buchbinder S, Vamshidar G, Celum C, McKirnan D, et al. (2005) Motivations for participating in an HIV vaccine efficacy trial. J Acquir Immune Defic Syndr 39: 359–364.
[23]  Macphail C, Delany-Moretlwe S, Mayaud P (2012) 'It's not about money, it's about my health': determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa. Patient Prefer Adherence 6: 579–588.
[24]  Jewkes R, Sikweyiya Y, Nduna M, Shai NJ, Dunkle K (2012) Motivations for, and perceptions and experiences of participating in, a cluster randomised controlled trial of a HIV-behavioural intervention in rural South Africa. Cult Health Sex 14: 1167–1182.
[25]  Kraft JM, Harvey SM, Thorburn S, Henderson JT, Posner SF, et al. (2007) Intervening with couples: assessing contraceptive outcomes in a randomized pregnancy and HIV/STD risk reduction intervention trial. Womens Health Issues 17: 52–60.
[26]  Institute G Unmet need for contraception in Developing Countries: levels and reasons for not using a methods. Available: http://www,guttmacherorg/pubs/2007/07/09?/or37pdf. Accessed 2013 June 25.
[27]  Stanback J, Thompson A, Hardee K, Janowitz B (1997) Menstruation requirements: a significant barrier to contraceptive access in developing countries. Stud Fam Plann 28: 245–250.
[28]  MacPhail C, Pettifor AE, Pascoe S, Rees HV (2007) Contraception use and pregnancy among 15–24 year old South African women: a nationally representative cross-sectional survey. BMC Med 5: 31.
[29]  Ngianga-Bakwin K, Stones RW (2005) Birth intervals and injectable contraception in sub-Saharan Africa. Contraception 71: 353–356.
[30]  Ross JA, Agwanda AT (2012) Increased use of injectable contraception in sub-Saharan Africa. Afr J Reprod Health 16: 68–80.
[31]  Kibuuka H, Guwatudde D, Kimutai R, Maganga L, Maboko L, et al. (2009) Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa. PLoS One 4: e5164.
[32]  Cleland J, Ali MM (2006) Sexual abstinence, contraception, and condom use by young African women: a secondary analysis of survey data. Lancet 368: 1788–1793.
[33]  Guest G, Johnson L, Burke H, Rain-Taljaard R, Severy L, et al. (2007) Changes in sexual behavior during a safety and feasibility trial of a microbicide/diaphragm combination: an integrated qualitative and quantitative analysis. AIDS Educ Prev 19: 310–320.
[34]  Marrazzo J (2013) VOICE: Oral TDF, Oral TDF/3TC, Vaginal TFV Gel as PrEP in African Women. CROI Abstract 26LB.


comments powered by Disqus

Contact Us


微信:OALib Journal