The biobehavioral Women's Health CoOp in Pretoria, South Africa: study protocol for a cluster-randomized design

Wendee M Wechsberg, William A Zule, Jacqueline Ndirangu, Tracy L Kline, Nathaniel F Rodman, Irene A Doherty, Scott P Novak, Charles M van der Horst, Wendee M Wechsberg, William A Zule, Jacqueline Ndirangu, Tracy L Kline, Nathaniel F Rodman, Irene A Doherty, Scott P Novak, Charles M van der Horst

Abstract

Background: South Africa has 6.4 million adults over the age of 15 living with HIV. Gender inequality issues continue to drive the HIV epidemic in South Africa, where Black African women bear the greatest HIV burden. Limited access to services; little capacity to negotiate sex and condom use; and other legal, social, and economic inequities make women highly vulnerable to HIV infection. Behavioral interventions have been shown to decrease risk behaviors, but they have been less successful in reducing HIV incidence. Conversely, biomedical prevention strategies have proven to be successful in reducing HIV incidence, but require behavioral interventions to increase uptake and adherence. Consequently, there is a need for integrated approaches that combine biomedical and behavioral interventions. Effective combination prevention efforts should comprise biomedical, behavioral, and structural programming proven in randomized trials that focuses on the driving forces and key populations at higher risk of HIV infection and transmission.

Methods/design: This prospective, geographically clustered randomized field experiment is enrolling participants into two arms: a control arm that receives standard HIV testing and referral for treatment; and an intervention arm that receives an evidence-based, woman-focused behavioral intervention that emphasizes risk reduction and retention, the Women's Health CoOp. We divided the city of Pretoria into 14 mutually exclusive geographic zones and randomized these zones into either the control arm or the intervention arm. Outreach workers are recruiting drug-using women from each zone. At baseline, eligible participants complete a questionnaire and biological testing for HIV, recent drug use, and pregnancy. Follow-up interviews are completed at 6 and 12 months.

Discussion: The biobehavioral intervention in this study merges an efficacious behavioral HIV prevention intervention for women with biomedical prevention through HIV treatment as prevention using a Seek, Test, Treat and Retain strategy. This combination biobehavioral intervention is designed to (1) improve the quality of life and reduce HIV infectiousness among women who are HIV positive, and (2) reduce HIV risk behaviors among women regardless of their HIV status. If efficacious, this intervention could help control the HIV epidemic in South Africa.

Trial registration: Trial registration no: NCT01497405.

Figures

Figure 1
Figure 1
Anticipated recruitment, intervention participation, follow-up, and allocation of clusters.

References

    1. UNAIDS . Global report: UNAIDS report on the global HIV/AIDS epidemic 2013. Geneva: UNAIDS; 2013.
    1. Rehle TM, Hallett TB, Shisana O, Pillay-van Wyk V, Zuma K, Carrara H, Jooste S. A decline in new HIV infections in South Africa: estimating HIV incidence from three national HIV surveys in 2002, 2005 and 2008. PLoS One. 2010;5(6):e11094. doi: 10.1371/journal.pone.0011094.
    1. Tanser F, de Oliveira T, Maheu-Giroux M, Barnighausen T. Concentrated HIV subepidemics in generalized epidemic settings. Curr Opin HIV AIDS. 2014;9(2):115–125. doi: 10.1097/COH.0000000000000034.
    1. Shisana O, Rehle T, Simbayi LC, Zuma K, Jooste S, Zungu N, Labadarios D, Onoya D. South African National HIV Prevalence, Incidence and Behaviour Survey, 2012. Cape Town: HSRC Press; 2014.
    1. Papworth E, Ceesay N, An L, Thiam-Niangoin M, Ky-Zerbo O, Holland C, Drame FM, Grosso A, Diouf D, Baral SD. Epidemiology of HIV among female sex workers, their clients, men who have sex with men and people who inject drugs in West and Central Africa. J Int AIDS Soc. 2013;16 Suppl 3:18751.
    1. Karim QA, Kharsany AB, Frohlich JA, Werner L, Mashego M, Mlotshwa M, Madlala BT, Ntombela F, Abdool Karim SS. Stabilizing HIV prevalence masks high HIV incidence rates amongst rural and urban women in KwaZulu-Natal, South Africa. Int J Epidemiol. 2011;40(4):922–930. doi: 10.1093/ije/dyq176.
    1. Coates TJ, Richter L, Caceres C. Behavioural strategies to reduce HIV transmission: how to make them work better. Lancet. 2008;372(9639):669–684. doi: 10.1016/S0140-6736(08)60886-7.
    1. Republic of South Africa . Country Progress Report on the Declaration of Commitment on HIV/AIDS Reporting Period: January 2008 - December 2009; Final Report. 2010.
    1. Shannon K, Strathdee SA, Goldenberg SM, Duff P, Mwangi P, Rusakova M, Reza-Paul S, Lau J, Deering K, Pickles MR, Boily MC: Global epidemiology of HIV among female sex workers: influence of structural determinants.Lancet13–29. HIV and Sex Worker Supplement, July, 2014
    1. Lowndes CM, Alary M, Labbe AC, Gnintoungbe C, Belleau M, Mukenge L, Meda H, Ndour M, Anagonou S, Gbaguidi A. Interventions among male clients of female sex workers in Benin, West Africa: an essential component of targeted HIV preventive interventions. Sex Transm Infect. 2007;83(7):577–581. doi: 10.1136/sti.2007.027441.
    1. Cote AM, Sobela F, Dzokoto A, Nzambi K, Asamoah-Adu C, Labbe AC, Masse B, Mensah J, Frost E, Pepin J. Transactional sex is the driving force in the dynamics of HIV in Accra, Ghana. AIDS. 2004;18(6):917–925. doi: 10.1097/00002030-200404090-00009.
    1. Mukandavire Z, Garira W. Effects of public health educational campaigns and the role of sex workers on the spread of HIV/AIDS among heterosexuals. Theor Popul Biol. 2007;72(3):346–365. doi: 10.1016/j.tpb.2007.07.002.
    1. Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, McIntyre J, Lingappa JR, Celum C. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010;375(9731):2092–2098. doi: 10.1016/S0140-6736(10)60705-2.
    1. Attia S, Egger M, Muller M, Zwahlen M, Low N. Sexual transmission of HIV according to viral load and antiretroviral therapy: systematic review and meta-analysis. AIDS. 2009;23(11):1397–1404. doi: 10.1097/QAD.0b013e32832b7dca.
    1. Das M, Chu PL, Santos GM, Scheer S, Vittinghoff E, McFarland W, Colfax GN. Decreases in community viral load are accompanied by reductions in new HIV infections in San Francisco. PLoS One. 2010;5(6):e11068. doi: 10.1371/journal.pone.0011068.
    1. Wood E, Kerr T, Marshall BD, Li K, Zhang R, Hogg RS, Harrigan PR, Montaner JS. Longitudinal community plasma HIV-1 RNA concentrations and incidence of HIV-1 among injecting drug users: prospective cohort study. BMJ. 2009;338:b1649. doi: 10.1136/bmj.b1649.
    1. Sandelowski M, Voils CI, Chang Y, Lee E-J. A systematic review comparing antiretroviral adherence descriptive and intervention studies conducted in the USA. AIDS Care. 2009;21(8):953–966. doi: 10.1080/09540120802626212.
    1. Eaton LA, Kalichman S. Risk compensation in HIV prevention: implications for vaccines, microbicides, and other biomedical HIV prevention technologies. Curr HIV/AIDS Rep. 2007;4(4):165–172. doi: 10.1007/s11904-007-0024-7.
    1. Venkatesh KK, Flanigan TP, Mayer KH. Is expanded HIV treatment preventing new infections? Impact of antiretroviral therapy on sexual risk behaviors in the developing world. AIDS. 2011;25(16):1939–1949. doi: 10.1097/QAD.0b013e32834b4ced.
    1. Cohen MS, Muessig KE, Smith MK, Powers KA, Kashuba AD. Antiviral agents and HIV prevention: controversies, conflicts, and consensus. AIDS. 2012;26(13):1585–1598. doi: 10.1097/QAD.0b013e3283543e83.
    1. Padian NS, Buve A, Balkus J, Serwadda D, Cates W., Jr Biomedical interventions to prevent HIV infection: evidence, challenges, and way forward. Lancet. 2008;372(9638):585–599. doi: 10.1016/S0140-6736(08)60885-5.
    1. UNAIDS . Combination HIV prevention: Tailoring and coordinating biomedical, behavioural and structural strategies to reduce new HIV infections. Geneva: UNAIDS; 2010.
    1. Kurth AE, Celum C, Baeten JM, Vermund SH, Wasserheit JN. Combination HIV prevention: significance, challenges, and opportunities. Curr HIV/AIDS Rep. 2011;8(1):62–72. doi: 10.1007/s11904-010-0063-3.
    1. Wechsberg WM, Luseno WK, Kline TL, Browne FA, Zule WA. Preliminary findings of an adapted evidence-based woman-focused HIV intervention on condom use and negotiation among at-risk women in Pretoria, South Africa. J Prev Interv Community. 2010;38(2):132–146. doi: 10.1080/10852351003640799.
    1. Wechsberg WM, Zule WA, Luseno WK, Kline TL, Browne FA, Novak SP, Ellerson RM. Effectiveness of an adapted evidence-based woman-focused intervention for sex workers and non-sex workers: the Women's Health CoOp in South Africa. J Drug Iss. 2011;41(2):233–252. doi: 10.1177/002204261104100205.
    1. Wechsberg WM, Smith FJ, Harris-Adeeyo T. AIDS education and outreach to IV drug users and the community: strategies and results. Psychol Addict Behav. 1992;6(Special Issue on AIDS and Substance Abuse):107–113. doi: 10.1037/h0080623.
    1. Wechsberg WM, Luseno WK, Lam WK. Violence against substance-abusing South African sex workers: intersection with culture and HIV risk. AIDS Care. 2005;17(Suppl 1):S55–64. doi: 10.1080/09540120500120419.
    1. Wechsberg WM, Luseno WK, Lam WK, Parry CD, Morojele NK. Substance use, sexual risk, and violence: HIV prevention intervention with sex workers in Pretoria. AIDS Behav. 2006;10(2):131–137. doi: 10.1007/s10461-005-9036-8.
    1. Wechsberg WM. Facilitating empowerment for women substance abusers at risk for HIV. Pharmacol Biochem Behav. 1998;61(1):158.
    1. Data harmonization projects. Seek, test, treat, and retain []
    1. Cawley C, Wringe A, Slaymaker E, Todd J, Michael D, Kumugola Y, Urassa M, Zaba B. The impact of voluntary counselling and testing services on sexual behaviour change and HIV incidence: observations from a cohort study in rural Tanzania. BMC Infect Dis. 2014;14:159. doi: 10.1186/1471-2334-14-159.
    1. Fonner VA, Denison J, Kennedy CE, O'Reilly K, Sweat M. Voluntary counseling and testing (VCT) for changing HIV-related risk behavior in developing countries. Cochrane Database Syst Rev. 2012;9:Cd001224.
Pre-publication history
    1. The pre-publication history for this paper can be accessed here:

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe