Browsing by Author "Maarschalk, Silvia."

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Disclosure of microbicide gel use to sexual partners: influence on adherence in the CAPRISA 004 trial.
(Springer., 2014) Mngadi, Kathryn Therese.; Maarschalk, Silvia.; Grobler, Anna Christina.; Mansoor, Leila Essop.; Fröhlich, Janet Ann.; Madlala, Bernadette T.; Ngcobo, Nelisiwe.; Abdool Karim, Salim Safurdeen.; Abdool Karim, Quarraisha.
Abstract available in pdf.
Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.
(American Association for the Advancement of Science., 2010) Abdool Karim, Salim Safurdeen.; Abdool Karim, Quarraisha.; Fröhlich, Janet Ann.; Grobler, Anna Christina.; Baxter, Cheryl.; Mansoor, Leila Essop.; Kharsany, Ayesha Bibi Mahomed.; Sibeko, Sengeziwe.; Mlisana, Koleka Patience.; Omar, Zaheen.; Gengiah, Tanuja Narayansamy.; Maarschalk, Silvia.; Arulappan, Natasha.; Mlotshwa, Mukelisiwe.; Morris, Lynn.; Taylor, Douglas.
The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
Mapping rural youth's experiences of school exclusion.
(2007) Maarschalk, Silvia.; Van der Riet, Mary Boudine.; Killian, Beverley Janet.
The South African context gives rise to a number of significant adversities that challenge the stability of the individual child and the survival of their families. The repercussions of these adversities are profound. Once risk begins to accumulate, the probability of a negative developmental trajectory increases. A group of South African children that are a particularly vulnerable, at risk, and marginalized group are those youth who are excluded from school. Access to the schooling system represents an important node of care and support with the potential of linking vulnerable children to key services. Eight youth from a town in a former homeland in rural KwaZulu Natal, who are excluded from the schooling system, participated in this research. The research aimed to map their experiences of school exclusion through a participatory photo interview technique. Using Bronfenbrenner's (1979) socio-ecological systems theory, this study has indicated that exclusion from school relates to risk factors present in the five contextual systems that a child functions within. From this research one can see how each risk factor adds to the web of exclusion that makes these youth hard to identify, access and help. The findings indicate that there is a need to further investigate the South African child care grant system and the impact it has on access to schooling, as well as to develop macrosystemic interventions to alleviate poverty.
Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial.
(Biomed Central, 2010) Abdool Karim, Quarraisha.; Kharsany, Ayesha Bibi Mahomed.; Fröhlich, Janet Ann.; Baxter, Cheryl.; Yende Zuma, Nonhlanhla.; Mansoor, Leila Essop.; Mlisana, Koleka Patience.; Maarschalk, Silvia.; Arulappan, Natasha.; Grobler, Anna Christina.; Sibeko, Sengeziwe.; Omar, Zaheen.; Gengiah, Tanuja Narayansamy.; Mlotshwa, Mukelisiwe.; Samsunder, Natasha.; Abdool Karim, Salim Safurdeen.
Background: Young women in sub-Saharan Africa bear a disproportionate burden of HIV infection compared to men but have limited options to reduce their HIV risk. Microbicides could fill an important HIV prevention gap for sexually active women who are unable to successfully negotiate mutual monogamy or condom use. Purpose: This paper describes the baseline sample characteristics in the CAPRISA 004 trial which assessed the safety and effectiveness of the vaginal microbicide, 1% tenofovir gel for HIV prevention in South Africa. Methods: This analysis assessed the baseline demographic, clinical and sexual behavior data of women screened and enrolled into the trial. The characteristics were summarized using descriptive summary measures; expressed as means and percent for categorical variables. Results: HIV prevalence at screening was 25.8% [95% Confidence Interval (CI):23.9-27.7). Of the 889 eligibly enrolled women who contributed follow-up data, rural participants recruited from a family planning (FP) clinic were younger, more likely to be living apart from their regular partner, reported lower coital frequency, had lower condom use (p < 0.001). In contrast, urban participants recruited from a sexually transmitted disease (STD) clinic reported higher numbers of lifetime sexual partners, new partners in the last 30 days and receiving money in exchange for sex (p < 0.001). Conclusion: The populations selected provide suitable diverse target groups for HIV prevention intervention studies.
Safety of tenofovir gel, a vaginal microbicide, in South African women: results of the CAPRISA 004 Trial.
(International Medical Press., 2012) Sokal, David C.; Abdool Karim, Quarraisha.; Sibeko, Sengeziwe.; Yende Zuma, Nonhlanhla.; Mansoor, Leila Essop.; Baxter, Cheryl.; Grobler, Anna Christina.; Fröhlich, Janet Ann.; Kharsany, Ayesha Bibi Mahomed.; Miya, Nomsa.; Mlisana, Koleka Patience.; Maarschalk, Silvia.; Abdool Karim, Salim Safurdeen.
Background: Tenofovir gel, used vaginally before and after coitus, reduced women’s acquisition of HIV by 39%. This is a safety assessment of tenofovir gel, including renal, bone, gastrointestinal, genital and haematological parameters. Methods: In the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, a double-blind, randomized placebo-controlled trial, 445 of the 889 eligibly enrolled women were assigned to tenofovir gel. All participants were advised to use the gel vaginally only, with one dose of gel within 12 h before and a second dose as soon as possible after sex, with no more than two doses in 24 h. Clinical and laboratory safety data were collected at monthly and quarterly visits, respectively. Genital assessments were undertaken at enrolment and quarterly thereafter, or as indicated. Results: Women assigned to tenofovir gel were exposed to an average monthly vaginal dose of 240 mg of tenofovir (six applications). In total, six women, three in each group, had mild creatinine elevations, all of which occurred in July/August 2008. The incidence of anaemia was 3.5 and 3.8 per 100 women-years in tenofovir and placebo groups, respectively (P=0.80). Of the six women (four tenofovir and two placebo) experiencing bone fractures, none were associated with abnormal phosphate or calcium values. The proportion of women with diarrhoea was higher in the tenofovir gel group (17% versus 11%; P=0.026). There was no significant increase of any genital adverse event in the tenofovir group. Conclusions: No significant renal, haematological, genital or bone effects were associated with the use of tenofovir gel. Aside from a puzzling increase in diarrhoea, tenofovir gel has an excellent safety profile.