A bio-behavioral intervention to decrease intravaginal practices and bacterial vaginosis among HIV infected Zambian women, a randomized pilot study

Maria L Alcaide, Maureen Chisembele, Emeria Malupande, Violeta J Rodriguez, Margaret A Fischl, Kristopher Arheart, Deborah L Jones, Maria L Alcaide, Maureen Chisembele, Emeria Malupande, Violeta J Rodriguez, Margaret A Fischl, Kristopher Arheart, Deborah L Jones

Abstract

Background: Intravaginal practices (IVP) (cleansing or introducing products inside the vagina for hygiene, health or to please sexual partners) are common among women with HIV. IVP increase the risk of developing bacterial Vaginosis (BV), the most common genital infection associated with transmission of sexually transmitted infections and HIV. This study tested a pilot intervention to reduce IVP and BV in HIV infected women in Zambia.

Methods: One hundred twenty-eight HIV infected women engaging in IVP were randomized to two conditions: enhanced standard of care (n = 70) and experimental (n = 58) from May 1, 2013 to February 28, 2014. All participants received a brief educational counseling session on discontinuation of IVP, and those with BV, were provided with medical treatment for BV. Women in the experimental condition received an additional group-based, culturally tailored intervention. Participants completed questionnaires assessing sexual risk factors and IVP and were assessed for BV using Nugent criteria at baseline, 6 months and 12 months.

Results: At 12-month, the proportion of self-reported use of IVPs decreased in the experimental condition: soap (28% vs. 47%); cloth or a rag (19% vs. 38%); and traditional medicines (22% vs. 42%) (all p < 0.05)) compared with the enhanced standard of care condition. The prevalence of BV at 6 and 12 months did not differ by study condition but averaging over study condition, prevalence of BV decreased from 64.2% at baseline to 15.6% at 6 months (p < 0.01) and to 23.6% at 12 months (p = 0.15). Using an enhanced standard of care approach and an enhanced standard of care + a group intervention, IVP and BV decreased over time, but the experimental condition had greater reduction in self-reported use of IVP.

Conclusions: Future studies should address interventions in communities with high burden of IVP, BV and HIV. Interventions that could be administered during routine medical care and decrease IVP and BV are needed, and should be considered part of women's health programs.

Trial registration number: NCT03134924 (retrospectively registered 21st April 2017).

Keywords: HIV shedding; Intravaginal practices; bacterial vaginosis.

Figures

Fig. 1
Fig. 1
Flow diagram of women enrolled and excluded during the study period. IVP = Intravaginal Practices. BV = Bacterial Vaginosis. SOC+ = Enhanced standard of care

References

    1. Hilber AM, Chersich MF, van de Wijgert JH, Rees H, Temmerman M. Vaginal practices, microbicides and HIV: what do we need to know? Sex Transm Infect. 2007;83(7):505–508. doi: 10.1136/sti.2007.028597.
    1. Allen CF, Desmond N, Chiduo B, Medard L, Lees SS, Vallely A, Francis SC, Ross DA, Hayes RJ. Intravaginal and menstrual practices among women working in food and recreational facilities in Mwanza, Tanzania: implications for microbicide trials. AIDS Behav. 2010;14(5):1169–1181. doi: 10.1007/s10461-010-9750-8.
    1. Hilber AM, Francis SC, Chersich M, Scott P, Redmond S, Bender N, Miotti P, Temmerman M, Low N. Intravaginal practices, vaginal infections and HIV acquisition: systematic review and meta-analysis. PLoS One. 2010;5(2):e9119. doi: 10.1371/journal.pone.0009119.
    1. McClelland RS, Lavreys L, Hassan WM, Mandaliya K, Ndinya-Achola JO, Baeten JM. Vaginal washing and increased risk of HIV-1 acquisition among African women: a 10-year prospective study. AIDS. 2006;20(2):269–273. doi: 10.1097/01.aids.0000196165.48518.7b.
    1. Chu TY, Hsiung CA, Chen CA, Chou HH, Ho CM, Chien TY, Chang HJ, Chou CY, Liou JD, Kan YY, et al. Post-coital vaginal douching is risky for non-regression of low-grade squamous intraepithelial lesion of the cervix. Gynecol Oncol. 2011;120(3):449–453. doi: 10.1016/j.ygyno.2010.11.006.
    1. Clark RA, Theall KP, Amedee AM, Kissinger PJ. Frequent douching and clinical outcomes among HIV-infected women. Sex Transm Dis. 2007;34(12):985–990.
    1. Low N, Chersich MF, Schmidlin K, Egger M, Francis SC, van de Wijgert JH, Hayes RJ, Baeten JM, Brown J, Delany-Moretlwe S, et al. Intravaginal practices, bacterial vaginosis, and HIV infection in women: individual participant data meta-analysis. PLoS Med. 2011;8(2):e1000416. doi: 10.1371/journal.pmed.1000416.
    1. Holmes KSF, Stamm W, Piot P, Wasserheit J, Corey L, et al. Sexually Transmitted Diseases. 4 2008.
    1. Laxmi U, Agrawal S, Raghunandan C, Randhawa VS, Saili A. Association of bacterial vaginosis with adverse fetomaternal outcome in women with spontaneous preterm labor: a prospective cohort study. J Matern Fetal Neonatal Med. 2012;25(1):64–67. doi: 10.3109/14767058.2011.565390.
    1. Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, et al. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251.
    1. Taha TE, Hoover DR, Dallabetta GA, Kumwenda NI, Mtimavalye LA, Yang LP, Liomba GN, Broadhead RL, Chiphangwi JD, Miotti PG. Bacterial vaginosis and disturbances of vaginal flora: association with increased acquisition of HIV. AIDS. 1998;12(13):1699–1706. doi: 10.1097/00002030-199813000-00019.
    1. Alcaide ML, Mumbi M, Chitalu N, Jones D. Vaginal cleansing practices in HIV infected Zambian women. AIDS Behav. 2013;17(3):872–878. doi: 10.1007/s10461-011-0083-z.
    1. Alcaide ML, Chisembele M, Mumbi M, Malupande E, Jones D. Examining targets for HIV prevention: intravaginal practices in Urban Lusaka, Zambia. AIDS Patient Care STDs. 2014;28(3):121–127. doi: 10.1089/apc.2013.0309.
    1. Mbikusita-Lewanika M, Stephen H, Thomas J. The prevalence of the use of 'dry sex' traditional medicines, among Zambian women, and the profile of the users. Psychology, health & medicine. 2009;14(2):227–238. doi: 10.1080/13548500802270364.
    1. Keller B. Marriage and medicine: women's search for love and luck. Afr Soc Res. 1978;26:489–5051978.
    1. Spring A. An indigenous therapeutic style and its consequences for natality: the Luvale of Zambia. In: Marshall JF, Polgar S, editors. Culture, natality, and family pl anning. Chapel Hill, North Carolina, Carolina Population Center, 1976. (Carolina Population Center Monograph No. 21) 1976. pp. 99–125.
    1. Masese L, McClelland RS, Gitau R, Wanje G, Shafi J, Kashonga F, Ndinya-Achola JO, Lester R, Richardson BA, Kurth A. A pilot study of the feasibility of a vaginal washing cessation intervention among Kenyan female sex workers. Sex Transm Infect. 2013;89(3):217–222. doi: 10.1136/sextrans-2012-050564.
    1. Esber A, Moyo P, Munjoma M, Francis S, van de Wijgert J, Chipato T, Turner AN. Cessation of intravaginal practices to prevent bacterial vaginosis: a pilot intervention in Zimbabwean women. Sex Transm Infect. 2015;91(3):183–188. doi: 10.1136/sextrans-2014-051764.
    1. Sivapalasingam S, McClelland RS, Ravel J, Ahmed A, Cleland CM, Gajer P, Mwamzaka M, Marshed F, Shafi J, Masese L, et al. An effective intervention to reduce intravaginal practices among HIV-1 uninfected Kenyan women. AIDS Res Hum Retrovir. 2014;30(11):1046–1054. doi: 10.1089/aid.2013.0251.
    1. Alcaide ML, Mumbi M, Chitalu N, Jones DL. An intervention to decrease intravaginal practices in hiv-infected women in zambia: a pilot study. J. Assoc. Nurses AIDS Care. 2013;24(3):219–226. doi: 10.1016/j.jana.2012.08.009.
    1. Alcaide ML, Chisembele M, Malupande E, Arheart K, Fischl M, Jones DL. A cross-sectional study of bacterial vaginosis, intravaginal practices and HIV genital shedding; implications for HIV transmission and women's health. BMJ Open. 2015;5(11):e009036. doi: 10.1136/bmjopen-2015-009036.
    1. Kalichman SC, Simbayi LC, Vermaak R, Cain D, Jooste S, Peltzer K. HIV/AIDS risk reduction counseling for alcohol using sexually transmitted infections clinic patients in Cape Town, South Africa. J Acquir Immune Defic Syndr. 2007;44(5):594–600. doi: 10.1097/QAI.0b013e3180415e07.
    1. van der Straten A, Cheng H, Minnis AM. Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe. J Int AIDS Soc. 2010;13:39. doi: 10.1186/1758-2652-13-39.
    1. Fisher WAFJ, Hartman J. The information-motivation-behavioral skills model: A general social psychological approach to understanding and promoting health behavior. In: Suls J, Wallston KA, editors. Social Psychological Foundations of Health and Illness. Malden: Blackwell Publishing Ltd; 2009.
    1. Kalichman SC, Picciano JF, Roffman RA. Motivation to reduce HIV risk behaviors in the context of the Information, Motivation and Behavioral Skills (IMB) model of HIV prevention. J Health Psychol. 2008;13(5):680–689. doi: 10.1177/1359105307082456.
    1. Fichorova RN. Guiding the vaginal microbicide trials with biomarkers of inflammation. J Acquir Immune Defic Syndr. 2004;37(Suppl 3):S184–S193.
    1. Klebanoff MA, Andrews WW, Yu KF, Brotman RM, Nansel TR, Zhang J, Cliver SP, Schwebke JR. A pilot study of vaginal flora changes with randomization to cessation of douching. Sex Transm Dis. 2006;33(10):610–613. doi: 10.1097/01.olq.0000216050.41305.c1.
    1. Kasaro MP, Husnik MJ, Chi BH, Reid C, Magure T, Makanani B, Tembo T, Ramjee G, Maslankowski L, Rabe L, et al. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study. Int J STD AIDS. 2016;28(5):467-75.
    1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505. doi: 10.1056/NEJMoa1105243.
    1. CONSORT reporting clinical trials. . Accessed 24 Oct 2016.

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