Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Vaginal Practices
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study statistician did not participate in randomization and the recruiter and laboratory personnel were blinded to the condition assignment. The participant was blind to their condition assignment. The reading of all the slides used to diagnose BV was performed by one trained laboratory technician blinded to the participant condition assignment. In case of unclear reading, the slide was reviewed by a second technician and the chief of the laboratory until an agreement was achieved; both the second technician and the chief of the laboratory were blind to the condition assignment of the participant.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental condition
The WASH (Women's and Sexual Health) intervention included the elements of the enhanced standard of care condition and in addition, a group-based, culturally-tailored intervention to enhance the uptake of the recommendations. Facilitators covered an intervention manual on risks associated with IVP, symptoms of vaginal infections, vaginal health, women's experience with alternative methods for vaginal care, and communication with partners about vaginal health and the risks associated with IVP.
干预措施: Women's and Sexual Health [WASH] (Behavioral)
Enhanced Standard of Care
This study provided an "enhanced standard of care" (SOC+) comparison condition, consisting of a genital tract examination, collection of a vaginal swab with gram stain of vaginal secretions, diagnosis of BV using the Nugent criteria and provision of medication (oral metronidazole) within 48 hours of the examination in women with Nugent score of 7-10, regardless of the presence of symptoms. In addition, at baseline, participants received an individual education session on the risk of engaging in IVP, advice to discontinue IVP, and tips for healthy vaginal hygiene, emphasizing avoiding IVP and suggesting replacing IVP by external vaginal cleansing.
干预措施: Enhanced Standard of Care (Behavioral)
结局指标
主要结局
Vaginal Practices
时间窗: 12-months
Information on intravaginal practices was collected using a culturally tailored questionnaire assessing specific products used for IVP. Questions to assess product use in the prior month utilized a dichotomous response option: product use (1 = yes, 0 = no).
次要结局
未报告次要终点
研究者
Maria Alcaide
Associate Professor
University of Miami