Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"

Vaginosis, Bacterial Clinical Trial

Official title:

Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134924
• Other study ID #: 20120418
• Status: Completed
• Phase: N/A
• First received: April 21, 2017
• Last updated: April 28, 2017
• Start date: May 3, 2013
• Est. completion date: February 5, 2014

Study information

• Verified date: April 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 5, 2014
• Est. primary completion date: February 5, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seropositivity
• Immunologic Deficiency Syndromes
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Behavioral:
• Women's and Sexual Health [WASH]
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.
• Enhanced Standard of Care
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.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

Zambia, 

References & Publications (3)

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 Nov 9;5(11):e009036. doi: 10.1136/bmjopen-2015-009036. — View Citation

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 Mar;28(3):121-7. doi: 10.1089/apc.2013.0309. Epub 2014 Feb 25. — View Citation

Alcaide ML, Cook R, Chisembele M, Malupande E, Jones DL. Determinants of intravaginal practices among HIV-infected women in Zambia using conjoint analysis. Int J STD AIDS. 2016 May;27(6):453-61. doi: 10.1177/0956462415585447. Epub 2015 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Practices	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).	12-months