Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
Condition: Vaginosis, Bacterial
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Vaginosis, Bacterial; HIV Seropositivity; Vaginal Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Women's and Sexual Health [WASH]; Enhanced Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The WASH was a group-based, 45-minute group session on vaginal health and healthy vaginal practices led by two trained facilitators. The sessions covered topics related to vaginal practices and the potential harm of vaginal practices.; The "enhanced standard of care" (SOC+) condition received a genital tract examination, collection of a vaginal swab with gram stain of vaginal secretions, diagnosis of BV, and medication as needed. At baseline participants received an individual education session on the risk of engaging in IVP and tips on discontinuing IVP.
Other intervention name(s): WASH
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The interventional study model used a parallel design, where an enhanced standard of care and intervention were used.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bacterial Vaginosis