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

NCT ID: NCT03134924

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-03
• Study Completion Date: 2014-02-05

Brief 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.

Conditions

Vaginosis, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Women's and Sexual Health [WASH]

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Enhanced Standard of Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

WASH

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Maria Alcaide

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

References

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.

Reference Type: BACKGROUND

PMID: 24568672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26553833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25957322 (View on PubMed)

Alcaide ML, Chisembele M, Malupande E, Rodriguez VJ, Fischl MA, Arheart K, Jones DL. A bio-behavioral intervention to decrease intravaginal practices and bacterial vaginosis among HIV infected Zambian women, a randomized pilot study. BMC Infect Dis. 2017 May 12;17(1):338. doi: 10.1186/s12879-017-2436-3.

Reference Type: DERIVED

PMID: 28494795 (View on PubMed)

Other Identifiers

20120418

Identifier Type: -

Identifier Source: org_study_id