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      Acceptability and Use of the Diaphragm and Replens ® Lubricant Gel for HIV Prevention in Southern Africa

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          Abstract

          The acceptability and use of the diaphragm and lubricant gel were assessed as part of a large randomized controlled trial to determine the effectiveness of the methods in women’s HIV acquisition. 2,452 intervention-arm women were enrolled at five Southern African clinics and followed quarterly for 12–24 months. Acceptability and use data were collected by face-to-face interviews at Month 3 and Exit. Participants were “very comfortable” with the physical mechanics of diaphragm use throughout the trial, and approval of the gel consistency, quantity and the applicator was high. At Exit, consistent disclosure of use (AOR 1.97, 95% CI: 1.10–3.55); an overall high diaphragm rating (AOR 1.84, 95% CI: 1.45–2.34) and perception of partner approval (AOR 1.75, 95% CI: 1.35–2.26) were the most significant acceptability factors independently associated with consistent use. Despite being female-initiated, disclosure of use to male partners and his perceived approval of the products were factors significantly associated with their consistent use.

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          Probability of HIV-1 transmission per coital act in monogamous, heterosexual, HIV-1-discordant couples in Rakai, Uganda.

          R Gray, M Wawer, R Brookmeyer … (2001)
          The probability of HIV-1 transmission per coital act in representative African populations is unknown. We aimed to calculate this probability overall, and to estimate how it is affected by various factors thought to influence infectivity. 174 monogamous couples, in which one partner was HIV-1 positive, were retrospectively identified from a population cohort in Rakai, Uganda. Frequency of intercourse and reliability of reporting within couples was assessed prospectively. HIV-1 seroconversion was determined in the uninfected partners, and HIV-1 viral load was measured in the infected partners. Adjusted rate ratios of transmission per coital act were estimated by Poisson regression. Probabilities of transmission per act were estimated by log-log binomial regression for quartiles of age and HIV-1 viral load, and for symptoms or diagnoses of sexually transmitted diseases (STDs) in the HIV-1-infected partners. The mean frequency of intercourse was 8.9 per month, which declined with age and HIV-1 viral load. Members of couples reported similar frequencies of intercourse. The overall unadjusted probability of HIV-1 transmission per coital act was 0.0011 (95% CI 0.0008-0.0015). Transmission probabilities increased from 0.0001 per act at viral loads of less than 1700 copies/mL to 0.0023 per act at 38 500 copies/mL or more (p=0.002), and were 0.0041 with genital ulceration versus 0.0011 without (p=0.02). Transmission probabilities per act did not differ significantly by HIV-1 subtypes A and D, sex, STDs, or symptoms of discharge or dysuria in the HIV-1-positive partner. Higher viral load and genital ulceration are the main determinants of HIV-1 transmission per coital act in this Ugandan population.
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            Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial.

            Michael Rosenblum, Guy de Bruyn, Tsungai Chipato … (2007)
            Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe. We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12-24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459. Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54%vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups. We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.
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              Comparison of female to male and male to female transmission of HIV in 563 stable couples. European Study Group on Heterosexual Transmission of HIV.

              J Brunet, RA Ancelle Park (1992)
              To identify risk factors for heterosexual transmission of HIV and to compare the efficiency of male to female and female to male transmission. Cohort study of heterosexual couples. Regular partners of HIV infected subjects were tested and both members of the couples interviewed every six months. HIV prevalence in partners was analysed according to the characteristics of the couples. Nine European countries. 563 couples comprising 156 female index patients with their 159 male partners and 400 male index patients with their 404 female partners. Partners reporting risk factors other than sexual contacts with the index patient were excluded. HIV infection in partners and high risk sexual behaviour. Overall, 19 (12%) male partners and 82 (20%) female partners were infected with HIV, suggesting that male to female transmission is 1.9 (95% confidence interval 1.1 to 3.3) times more effective than female to male transmission. An advanced stage of HIV infection in the index patient (odds ratio 17.6; 4.9 to 62.7) and sexual contacts during menses (3.4; 1.0 to 11.1) increased the risk of female to male transmission and stage of infection (2.7; 1.5 to 4.9), anal sex (5.1; 2.9 to 8.9), and age of the female partner (3.9; 1.2 to 13.0 for age > 45 years) increased the risk of male to female transmission. None of the 24 partners who had used condoms systematically since the first sexual contact was infected. Several factors which potentiate the risk of transmission through unprotected vaginal intercourse have been identified. Knowledge of these factors could be helpful for counselling patients infected with HIV and their sexual partners.
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                Author and article information

                Contributors
                : +1-310-8372772 , +1-310-8412772 , emontgomery@rti.org
                Journal
                Journal ID (nlm-ta): AIDS Behav
                Title: AIDS and Behavior
                Publisher: Springer US (Boston )
                ISSN (Print): 1090-7165
                ISSN (Electronic): 1573-3254
                Publication date (Electronic): 10 September 2009
                Publication date PMC-release: 10 September 2009
                Publication date (Print): June 2010
                Volume: 14
                Issue: 3
                Pages: 629-638
                Affiliations
                [1 ]Women’s Global Health Imperative, RTI International, San Francisco Project Office, 114 Sansome Street, Suite 500, San Francisco, CA 94104 USA
                [2 ]Infectious Diseases Epidemiology Unit, Department of Epidemiology, London School of Hygiene and Tropical Medicine, London, UK
                [3 ]Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, CA USA
                [4 ]University of Zimbabwe-University of California San Francisco Research Collaborative Programme in Women’s Health, Harare, Zimbabwe
                [5 ]Ibis Reproductive Health, Cambridge, MA USA
                [6 ]Perinatal HIV Research Unit, Johannesburg, South Africa
                [7 ]Medical Research Council, Kwazulu-Natal, South Africa
                [8 ]University of California, Berkeley, School of Public Health, Berkeley, CA USA
                Article
                Publisher ID: 9609
                DOI: 10.1007/s10461-009-9609-z
                PMC ID: 2865647
                PubMed ID: 19757018
                SO-VID: 6bf6c3a6-22f7-491c-9742-6cf37ec4afe0
                Copyright © © The Author(s) 2009
                History
                Date received : 30 March 2009
                Date accepted : 25 August 2009
                Categories
                Subject: Original Paper
                Custom metadata
                issue-copyright-statement © Springer Science+Business Media, LLC 2010

                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: diaphragm,zimbabwe,product adherence,hiv prevention,acceptability,lubricant gel,south africa
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: diaphragm, zimbabwe, product adherence, hiv prevention, acceptability, lubricant gel, south africa

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