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

NCT03134924 | Completed DMC

• 1 other identifier: 20120418
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginosis, Bacterial

Keywords

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental condition

EXPERIMENTAL

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.

Behavioral: Women's and Sexual Health [WASH]

Enhanced Standard of Care

OTHER

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.

Behavioral: Enhanced Standard of Care

Interventions

Women's and Sexual Health [WASH] 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.

Also known as: WASH

Experimental condition

Enhanced Standard of Care 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.

Enhanced Standard of Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Participants were women living with HIV-1 infection, at least 18 years of age, receiving antiretroviral therapy (ART), engaging in intravaginal practices and vaginal intercourse with men in the month prior to enrolment, and living in the Lusaka metropolitan area. Because the primary outcomes were intravaginal practices and bacterial vaginosis, participants had to be female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (4)

• 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.

  PMID: 24568672 BACKGROUND

• 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.

  PMID: 26553833 BACKGROUND

• 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.

  PMID: 25957322 BACKGROUND

• 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.

  PMID: 28494795 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Sexual Health; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study statistician did not participate in randomization and the recruiter and laboratory personnel were blinded to the condition assignment. The participant was blind to their condition assignment. The reading of all the slides used to diagnose BV was performed by one trained laboratory technician blinded to the participant condition assignment. In case of unclear reading, the slide was reviewed by a second technician and the chief of the laboratory until an agreement was achieved; both the second technician and the chief of the laboratory were blind to the condition assignment of the participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The interventional study model used a parallel design, where an enhanced standard of care and intervention were used.

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 1, 2017
• Study Start: May 3, 2013
• Primary Completion: February 5, 2014
• Study Completion: February 5, 2014
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)