Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
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. A total of 128 HIV
 infected women engaging in IVP were randomized to two conditions: enhanced standard of care
 (n = 70) and experimental (n = 58). 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.
Zambia has high rates of women of childbearing age infected with Human Immune Deficiency
 Virus (HIV). The majority (93%) engage in intravaginal practices (here referred to as IVP) by
 internal cleansing (intravaginal cleansing) or by inserting products inside the vagina
 (intravaginal insertion). IVP are culturally driven practices associated with an increased
 risk of HIV transmission and may play an important role in exacerbating the HIV epidemic
 across sub-Saharan Africa.

 This application proposes to 1) evaluate the long term impact of a bio-behavioral
 intervention targeting VP among HIV infected women (n=128) in Lusaka, Zambia, and 2) assess
 the relative contributions of VP and bacterial vaginosis (BV) to lower genital tract
 inflammation and HIV shedding. Study aims will address the following:

 Aim 1. To develop and evaluate the long term impact of a culturally tailored bio-behavioral
 intervention aimed to decrease IVP in HIV positive women and evaluate the relative
 contribution of IVP and BV to lower genital inflammation and shedding of HIV.

 Aim 1.1. To develop and evaluate the long term impact of a bio-behavioral intervention to
 decrease IVP.

 Intra vaginal practices, as culturally driven and condoned behaviors, are difficult to
 modify. It is hypothesized that a culturally tailored bio-behavioral intervention is needed
 to decrease IVP, and that women participating in the intervention condition will reduce IVP
 in comparison with women in a time matched control condition. Experimental approach: Women
 engaging in IVP will be randomly assigned to one of two conditions (intervention or control).
 IVP will be evaluated and compared over 12 months.

 Aim 1.2. To compare rates of BV, lower genital tract inflammatory markers and HIV shedding in
 HIV infected women engaging in VP with and without BV.

 Due to the close relationship between IVP and BV, it is difficult to determine the relative
 contribution of each to lower genital tract inflammation and HIV shedding. It is hypothesized
 that women engaging in IVP with BV will have similar levels of both lower genital tract
 inflammatory cytokines and HIV viral load to those without BV. Experimental approach: Vaginal
 secretions and cervicovaginal fluid will be collected from women engaging in IVP. The
 presence of BV, inflammatory cytokines (IL-6 and IL-8), and HIV RNA will be determined by
 gram stain, ELISA and PCR techniques respectively, and compared in women that engage in IVP
 with and without BV.

 Aim 1.3. To compare BV, lower genital inflammatory markers and shedding of HIV in HIV
 seropositive women participating in the intervention versus control condition.

 Interventions to decrease IVP have the goal of reducing BV and associated adverse health
 outcomes. It is hypothesized that the bio-behavioral intervention will decrease BV, lower
 genital tract inflammation and HIV shedding. Experimental approach: Laboratory assessments
 used for Aim 1.2 will be repeated and compared at baseline, 6 and 12 months.
Inclusion Criteria:

 -  Women recruited

 -  Living with HIV-1 infection

 -  At least 18 years of age,

 -  Receiving antiretroviral therapy

 -  Intravaginal practices

 -  Vaginal intercourse with men in the month prior to enrolment

 -  Living in the Lusaka metropolitan area

 Exclusion Criteria:

 -  Pregnant

 -  Being on hormonal contraception

 -  Having an intrauterine device (IUD) in place to avoid the potential for induced
 changes in inflammatory cytokines in the genital mucosa due to contraception.