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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03134924
• Date of registration: 21/04/2017
• Prospective Registration: No
• Primary sponsor: University of Miami
• Public title: Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
• Scientific title: Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
• Date of first enrolment: May 3, 2013
• Target sample size: 128
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03134924
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Zambia

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vaginosis, Bacterial

Intervention(s)

Behavioral: Women's and Sexual Health [WASH]

Behavioral: Enhanced Standard of Care

Primary Outcome(s)

Vaginal Practices [Time Frame: 12-months]

Secondary ID(s)

20120418

Source(s) of Monetary Support

Please refer to primary and secondary sponsors