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

NCT03134924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-05-01

No results posted yet for this study

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.

Conditions

  • Vaginosis, Bacterial

Interventions

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.

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-03
Primary Completion
2014-02-05
Completion
2014-02-05

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134924 on ClinicalTrials.gov