Vaginosis, Bacterial Clinical Trial
Official title:
Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
Verified date | April 2017 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Zambia | University Teaching Hospital | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
Zambia,
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
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 |
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