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1.
AIDS Care ; 36(3): 326-342, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37734338

RESUMEN

Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study - where women were offered the dapivirine vaginal ring after two pivotal trials were completed - through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled (n = 60). Access to an effective user-initiated HIV prevention product was one of the main reasons women joined HOPE. Although many participants worried that their male partners might expose them to HIV, they chose to remain in their relationships and avoid conflict or confrontation with their partners by discreetly using the ring to protect themselves. Other reasons for joining were quality healthcare, reimbursement and altruism. Researchers should better understand social and personal motivators behind research participation in order to recognize community sociocultural norms and its influences on product acceptability and adherence challenges.


Asunto(s)
Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Pirimidinas , Humanos , Masculino , Femenino , Sudáfrica , Motivación , Uganda , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico
2.
AIDS Care ; 35(5): 739-744, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-35503713

RESUMEN

After decades of research, South African women continue to have the highest burden of HIV in the world. The aim of the study is to investigate the impact of marital status on HIV using population and community-level data sources. We included data 13,469 and 5682 South African women who participated to South African HIV behavioural surveys in 2002-2012 and 2017, respectively. HIV prevalence and incidence rates were significantly higher among single/not-cohabiting women compared to those married/cohabiting with a partner in all survey participants (adjusted odds ratio (aOR): 1.60 and 1.58 in 2002-2012 and 2017, respectively). A quarter of the HIV diagnoses were attributed to those who were single/not-cohabiting women (population attributable risk (PAR%): 25% and 24%, respectively). More than 40% of the HIV infections were exclusively associated with single women (PAR%: 42%, 95% CI: 33%, 51%). Our results provided strong evidence for the profound impact of marital status on excess HIV infection rates. Targeting and reaching single/not-cohabiting women with multiple risk factors can potentially play a crucial role in the trajectories of the epidemic.


Asunto(s)
Infecciones por VIH , Humanos , Femenino , Infecciones por VIH/epidemiología , Sudáfrica/epidemiología , Estado Civil , Factores de Riesgo , Encuestas y Cuestionarios , Prevalencia
3.
Afr J AIDS Res ; 22(2): 123-130, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37337820

RESUMEN

Background: Optimal adherence to antiretroviral therapy (ART) is crucial for the effective management of HIV. Mental disorders often co-occur with HIV infection which often compromises ART adherence. Little is known about ART adherence in psychiatric settings in sub-Saharan Africa.Aims: This study aimed at exploring the health care providers' perspectives on ART adherence among psychiatric inpatients. The study further assessed the facilitators and strategies enhancing ART adherence in hospitalised psychiatric patients.Methods: In-depth interviews were conducted with 25 health care providers at the Sbrana Psychiatric Hospital in Botswana. Interviews were focused on barriers and facilitators to psychiatric inpatients' adherence to ART, and strategies and recommendations to support adherence. Data were manually analysed using a thematic analysis approach.Results: Key barriers were lack of insight, HIV-related stigma, lack of HIV-related knowledge, antiretroviral side effects and delays in re-initiating ART. Facilitators of ART adherence included motivation to be discharged from the hospital, fear of being sick, peer support, longer duration of hospitalisation, good provider-patient relationships, good diet, privacy and confidentiality and a single-tablet regimen. Health care providers described the various strategies currently used to support adherence, including directly observed therapy and family support, and recommended potential approaches to enhance psychiatric inpatient adherence to ART, including the use of injectable antiretrovirals and the introduction of halfway house centres.Conclusions: Findings from this study revealed unique insights into the numerous factors that influence ART adherence among psychiatric inpatients, and underscore the need to implement tailored strategies to support ART adherence in this population with complex health needs.


Asunto(s)
Infecciones por VIH , Humanos , Infecciones por VIH/epidemiología , Pacientes Internos , Cumplimiento de la Medicación/psicología , Botswana , Investigación Cualitativa , Antirretrovirales/uso terapéutico
4.
GeoJournal ; : 1-17, 2023 Mar 07.
Artículo en Inglés | MEDLINE | ID: mdl-38625344

RESUMEN

South Africa also has the highest burden of coronavirus disease 2019 (COVID-19) related comorbidities in Africa. We aimed to quantify the temporal and geospatial changes in unemployment, food insecurity, and their combined impact on depressive symptoms among South Africans who participated into several rounds of national surveys. We estimated the population-attributable risk percent (PAR%) for the combinations of the risk factors after accounting for their correlation structure in multifactorial setting. Our study provided compelling evidence for immediate and severe effect of the pandemic where 60% of South Africans reported household food insecurity or household hunger, shortly after the pandemic emerged in 2020. Despite the grants provided by the government, these factors were also identified as the most influential risk factors (adjusted odds ratios (aORs) ranged from 2.06 to 3.10, p < 0.001) for depressive symptoms and collectively associated with 62% and 53% of the mental health symptoms in men and women, respectively. Similar pattern was observed among pregnant women and 41% of the depressive symptoms were exclusively associated with those who reported household hunger. However, aORs associated with the concerns around pandemic and vaccine were mostly not significant and ranged from 1.12 to 1.26 which resulted substantially lower impacts on depressive symptoms (PAR%:7%-and-14%). Our findings suggest that South Africa still has unacceptably high rates of hunger which is accelerated during the pandemic. These results may have significant clinical and epidemiological implications and may also bring partial explanation for the low vaccine coverage in the country, as priorities and concerns are skewed towards economic concerns and food insecurity.

5.
S Afr J Psychiatr ; 29: 1990, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36876029

RESUMEN

Background: The high prevalence of HIV among psychiatric inpatients is well-documented, yet little is known about the provision of HIV services for these patients. Aim: This qualitative study aimed to explore and understand healthcare providers' challenges with providing HIV services to psychiatric inpatients. Setting: This study was conducted at the national psychiatric referral hospital in Botswana. Methods: The authors conducted in-depth interviews with 25 healthcare providers serving HIV-positive psychiatric inpatients. Data analysis was performed using a thematic analysis approach. Results: Healthcare providers reported challenges with transporting patients to access off-site HIV services, longer waiting periods for antiretroviral therapy (ART) initiation, patient confidentiality, fragmented services for treatment of comorbidities, and a lack of patient data integration between the national psychiatric referral hospital and other facilities such as the Infectious Diseases Care Clinic (IDCC) at the nearby district hospital. Providers' recommendations for addressing these challenges included the establishment of an IDCC at the national psychiatric referral hospital, connecting the psychiatric facility to the patient data management system to ensure integration of patient data, and provision of HIV-related in-service training to nurses. Conclusion: Psychiatric healthcare providers advocated for on-site integration of care for psychiatric illness and HIV among inpatients to address the challenges of ART provision. Contribution: The findings suggest the need to improve the provision of HIV services in the psychiatric hospitals in order to ensure better outcomes for this often-overlooked population. These findings are useful in improving clinical practice for HIV in psychiatric settings.

6.
Prev Med ; 163: 107222, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36027992

RESUMEN

South Africa has one of the world's highest proportions of hypertensive individuals, which has become a major public health problem. Understanding the temporal and spatial patterns in hypertension rates is crucial for evaluating the existing prevention and care models, which have not been fully understood in South Africa. The geoadditive models were used to quantify the geographical clustering of hypertension in the Black South African population enrolled in the most recent cross-sectional national surveys (2008-2017). Population-attributable risks were calculated for modifiable risk factors. 80,270 men (41%) and women (59%) aged 15+ were included. Using the 2017 guidelines, 52% of the men and 51% of the women were classified as hypertensive. As expected, these proportions were slightly lower when we used the previous guidelines (48% and 47% for men and women, respectively). There was significant geospatial heterogeneity in hypertension prevalence with substantial province-specific disparities. Western, Northern, and Eastern Capes were the most significant provinces, with >50% of the hypertensive men and women. The population-level impact of obesity remained high in all provinces, where 33%-to-57% and 47%-to-65% of hypertensives were exclusively associated with obese/overweight men and women respectively. Despite some improvements in certain areas, most of the country is behind the targeted levels set in 2011/2013. Identifying the most relevant risk factors and their sub-geographical-level contributions to hypertension may have significant public health implications for developing and implementing cost-effective prevention programs to raise awareness of healthy diet and lifestyle behaviours.


Asunto(s)
Hipertensión , Estudios Transversales , Femenino , Humanos , Hipertensión/epidemiología , Estilo de Vida , Masculino , Obesidad/epidemiología , Prevalencia , Factores de Riesgo
7.
AIDS Behav ; 26(6): 1923-1932, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35064389

RESUMEN

Women account for a disproportionate percentage of new HIV infections in sub-Saharan Africa indicating a need for female-initiated HIV prevention options congruent with their lifestyles. The dapivirine vaginal ring for HIV prevention is one such option. We explored the interest of women, who used this ring during the Microbicide Trials Network's ASPIRE and HOPE studies, in using the ring post-licensure and what they perceived as important considerations for future use. We also explored perspectives of HOPE participants' male partners on their involvement in their partners' future ring use. Women appeared keen to use the ring in the future and expressed desires for easy access, support for both ongoing and new users and intense community engagement. In parallel, male partners indicated high levels of interest in supporting their partners' ring use and being involved in ring use decision making. These data offer important insights for ring rollout planning and engagement activities.


Asunto(s)
Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Masculino , Pirimidinas/uso terapéutico
8.
AIDS Behav ; 26(5): 1597-1606, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-34727272

RESUMEN

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.


Asunto(s)
Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Pirimidinas
9.
Clin Infect Dis ; 72(1): 50-60, 2021 01 23.
Artículo en Inglés | MEDLINE | ID: mdl-31900486

RESUMEN

BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).


Asunto(s)
Vacunas contra el SIDA , Infecciones por VIH , VIH-1 , Vacunas contra el SIDA/uso terapéutico , Adulto , ADN , Anticuerpos Anti-VIH , Infecciones por VIH/prevención & control , VIH-1/genética , Humanos , Inmunización Secundaria , Inmunogenicidad Vacunal , Polisorbatos , Sudáfrica , Escualeno , Tanzanía , Zambia
10.
AIDS Behav ; 25(6): 1890-1900, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33389318

RESUMEN

The dapivirine vaginal ring has been well-tolerated and shown to prevent HIV in clinical trials. The ring is female initiated, yet endorsement for use is sought from male partners in many relationships. In clinical studies, participants have expressed worries about men detecting rings during vaginal sex, which introduces concerns about product use disclosure, sexual pleasure, penile harm, inter-partner dynamics, and ring removals. This study reports African men's firsthand sexual experiences with the ring. Qualitative data were captured through 11 focus group discussions and one in-depth interview with 54 male partners of ring-users at six research sites in Malawi, South Africa, Uganda and Zimbabwe. Following a semi-structured guide, and using demonstration rings, vulva and penis models, men were asked to discuss the ring's impact on sex and views on male engagement and ring use. Interviews were facilitated by local male social scientists, audio-recorded, translated into English, and analyzed thematically. 22 (41%) of the male partners reported feeling the ring during sex, often attributed to perceived incorrect insertion. Many men described the ring as "scratching" the tip of their penises, and sensations of "prodding" something that "blocked" the vagina and prohibited "full entry". In most cases, feelings dissipated with time or when sexual fluids increased. Less common descriptions included perceiving the vaginal texture, wetness and size as different, which increased pleasure for some, and decreased for others. Over half (59%) never noticed the ring; some attempting and failing to feel it during intercourse. A majority of men reported that the ring did not lead to changes in sexual positions, feelings, frequency or experience of sex, although some were initially afraid that the ring was a "magic snake" or "potion". Male partners expressed strong opinions that ring use was a shared prevention responsibility that men should be engaged in, especially for maintaining trust and open communication in relationships. The ring was noticed by many male partners, particularly during women's initial stages of ring use, although this led to few sexual problems or changes. Nevertheless, results suggest that risk of ring discovery should be discussed with women to mitigate any potential negative reactions or social harm. Strategies to increase male partner engagement will enhance support of this prevention method for women.


Asunto(s)
Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Malaui , Masculino , Pirimidinas , Conducta Sexual , Parejas Sexuales , Sudáfrica , Uganda , Zimbabwe
11.
PLoS Med ; 17(5): e1003117, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32442195

RESUMEN

BACKGROUND: DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle. METHODS AND FINDINGS: The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects. CONCLUSIONS: In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.


Asunto(s)
Vacunas contra el SIDA/inmunología , Anticuerpos Neutralizantes/inmunología , Anticuerpos Anti-VIH/inmunología , Adulto , Formación de Anticuerpos/inmunología , ADN/genética , Método Doble Ciego , Femenino , Vectores Genéticos , Antígenos VIH/inmunología , Infecciones por VIH/prevención & control , VIH-1/genética , VIH-1/inmunología , Humanos , Masculino , Plásmidos/genética , Vacunación/métodos , Adulto Joven
12.
AIDS Behav ; 22(7): 2172-2180, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28956191

RESUMEN

Studies have shown that women diagnosed with herpes simplex virus-2 (HSV-2) have a higher risk for bacterial vaginosis (BV) infection. We investigated the presence of HSV-2 infections as a risk factor for incident BV infections in high risk, Human immunodeficiency virus (HIV) uninfected women enrolled in a HIV prevention trial in Durban, South Africa. The Vaginal and Oral Interventions to Control the Epidemic trial was a multicentre, double blinded, randomized controlled trial which was designed to estimate the effectiveness of daily treatment with vaginal tenofovir gel, oral tenofovir disoproxil fumarate and oral Truvada in preventing HIV-1 infection in women. Women provided samples for the diagnosis of HSV-2 and BV. The presence of HSV-2 antibodies was detected using HerpeSelect™ ELISA IgG. Bacterial vaginosis was diagnosed using the Nugent scoring system. To assess the risk of BV incidence, modelled as a time-dependent variable, we used the Andersen-Gill model with robust variance estimation and Efron methods for ties. Overall, 2750 women were enrolled in the VOICE trial at our study sites. Women who had a HSV-2 infection at enrolment were shown to be at increased risk for incident BV infections (adjusted hazard ratio 1.17, 95% CI 1.08, 1.27, p ≤ 0.001). In addition, being of a young age, being unmarried and having a partner that has other partners were significantly associated with subsequent BV infection. Our findings therefore advocate the need for strengthening STI prevention efforts among women in high burden STI settings.


Asunto(s)
Países en Desarrollo , Herpes Genital/epidemiología , Herpesvirus Humano 2 , Vaginosis Bacteriana/epidemiología , Administración Intravaginal , Administración Oral , Adulto , Estudios Transversales , Método Doble Ciego , Combinación Emtricitabina y Fumarato de Tenofovir Disoproxil/administración & dosificación , Femenino , Geles , Infecciones por VIH/prevención & control , Seronegatividad para VIH , Humanos , Incidencia , Factores de Riesgo , Sudáfrica/epidemiología , Tenofovir/administración & dosificación , Sexo Inseguro , Adulto Joven
13.
AIDS Behav ; 22(1): 325-336, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-28470458

RESUMEN

We aimed to develop a HIV risk scoring algorithm for targeted screening among women in South Africa. We used data from five biomedical intervention trials (N = 8982 Cox regression models were used to create a risk prediction algorithm and it was internally and externally validated using standard statistical measures; 7-factors were identified as significant predictors of HIV infection: <25 years old, being single/not cohabiting, parity (<3), age at sexual debut (<16), 3+ sexual partners, using injectables and diagnosis with a sexually transmitted infection(s). A score of ≥25 (out of 50) was the optimum cut point with 83% (80%) sensitivity in the development (validation) dataset. Our tool can be used in designing future HIV prevention research and guiding recruitment strategies as well as in health care settings. Identifying, targeting and prioritising women at highest risk will have significant impact on preventing new HIV infections by scaling up testing and pre-exposure prophylaxis in conjunction with other HIV prevention modalities.


Asunto(s)
Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Vigilancia de la Población , Evaluación de Programas y Proyectos de Salud/métodos , Medición de Riesgo/métodos , Conducta Sexual , Adulto , Algoritmos , Control de Enfermedades Transmisibles , Composición Familiar , Femenino , Infecciones por VIH/diagnóstico , Infecciones por VIH/epidemiología , Humanos , Profilaxis Pre-Exposición , Parejas Sexuales , Sudáfrica , Adulto Joven
14.
AIDS Behav ; 22(2): 437-446, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29151197

RESUMEN

Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants' sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners' interaction with or reaction to the ring. In maintaining positive relationships, women were concerned about partners' discovering ring use and about ensuring that partners had a good sexual experience with them. Finally women were concerned about how they themselves experienced sex with the ring. Some found that the ring made the vaginal environment more desirable for their partners and themselves.


Asunto(s)
Fármacos Anti-VIH/administración & dosificación , Antiinfecciosos/administración & dosificación , Coito/psicología , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH/prevención & control , Pirimidinas/administración & dosificación , Conducta Sexual , Parejas Sexuales , Adolescente , Adulto , Fármacos Anti-VIH/uso terapéutico , Antiinfecciosos/uso terapéutico , Femenino , Humanos , Malaui , Aceptación de la Atención de Salud , Pirimidinas/uso terapéutico , Sudáfrica , Uganda , Zimbabwe
15.
AIDS Behav ; 20(11): 2709-2714, 2016 11.
Artículo en Inglés | MEDLINE | ID: mdl-27146827

RESUMEN

Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting. ClinicalTrials.gov number: NCT00705679.


Asunto(s)
Fármacos Anti-VIH/uso terapéutico , Drogas en Investigación/uso terapéutico , Combinación Emtricitabina y Fumarato de Tenofovir Disoproxil/uso terapéutico , Infecciones por VIH/prevención & control , Infecciones por VIH/psicología , Profilaxis Pre-Exposición , Trastornos Relacionados con Sustancias/psicología , Tenofovir/uso terapéutico , Administración Oral , Adulto , Método Doble Ciego , Femenino , Humanos , Cumplimiento de la Medicación , Sudáfrica , Cremas, Espumas y Geles Vaginales/uso terapéutico , Adulto Joven
16.
J Med Ethics ; 41(3): 281-3, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25227554

RESUMEN

UNLABELLED: We report the case of an HIV prevention clinical trial participant who was referred to a local hospital for investigation and management of an incidental finding unrelated to her study participation. This case illustrates the complexities in the management of incidental findings within the context of clinical trials and highlights the importance of ethical oversight of trials. TRIAL REGISTRATION NUMBER: Protocol number ISRCTN64716212.


Asunto(s)
Carcinoma de Células Escamosas/diagnóstico , Infecciones por VIH/prevención & control , Histerectomía , Hallazgos Incidentales , Prueba de Papanicolaou , Infecciones por Papillomavirus/diagnóstico , Investigadores/ética , Responsabilidad Social , Neoplasias del Cuello Uterino/diagnóstico , Carcinoma de Células Escamosas/cirugía , Carcinoma de Células Escamosas/virología , Ensayos Clínicos como Asunto , Comités de Ética en Investigación , Ética en Investigación , Femenino , Humanos , Histerectomía/métodos , Persona de Mediana Edad , Obligaciones Morales , Infecciones por Papillomavirus/complicaciones , Derivación y Consulta , Sudáfrica , Neoplasias del Cuello Uterino/cirugía , Neoplasias del Cuello Uterino/virología
17.
AIDS Res Ther ; 11: 31, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25243015

RESUMEN

BACKGROUND AND OBJECTIVES: Sexually transmitted infections (STIs) contribute largely to the burden of health in South Africa and are recognized as major contributors to the human immunodeficiency virus (HIV) epidemic. Young women are particularly vulnerable to STIs. The purpose of this secondary analysis was to examine the risk factors associated with prevalent and incident STIs among women who had participated in three clinical trials. METHODS: A total of 5,748 women were screened and 2293 sexually active, HIV negative, non-pregnant women were enrolled in three clinical trials in Kwazulu-Natal, South Africa. The prevalence of individual STIs Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), syphilis, and Trichomonas vaginalis (TV) was assessed at screening; and incident infections were evaluated over a 24 month period. RESULTS: Overall, the combined study population of all three trials had a median age of 28 years (inter-quartile range (IQR):22-37), and a median duration of follow-up of 12 months. Prevalence of STIs (CT, NG, TV, or syphilis) was 13% at screening. The STI incidence was estimated to be 20/100 women years. Younger women (<25 years, p < 0.001), women who were unmarried (p < 0.001) and non-cohabiting women (p < 0.001) were shown to be at highest risk for incident STIs. CONCLUSIONS: These results confirm the extremely high prevalence and incidence of STIs among women living in rural and urban communities of KwaZulu-Natal, South Africa, where the HIV epidemic is also particularly severe. These findings strongly suggest an urgent need to allocate resources for STI and HIV prevention that mainly target younger women. TRIAL REGISTRATION: Clinical Trials.gov, NCT00121459.

18.
Int J STD AIDS ; 35(7): 535-542, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38492207

RESUMEN

BACKGROUND: South African women have the highest burden of HIV infections globally. We investigated the temporal trends and the impact of key factors associated with HIV diagnosis among a nationally representative cohort of South African women. METHODS: Total of 24,657 women who participated in the National HIV, Behaviour and Health Surveys conducted from 2002-to-2017. RESULTS: Despite decades-long prevention efforts, we observed a significant increase in HIV prevalence over time (22% in 2002 to 21% in 2005-2008 and 29% in 2012-2017). Overall, 46% of the women living with HIV were not aware of their risk of HIV with age-specific disparities. Our findings revealed compelling evidence between HIV seropositivity and high HIV risk-perception (adjusted Odds Ratio (aOR):1.47 to 3.29) which increased overtime and exceeded the other factors. At a population-level, 45% of the HIV diagnoses were exclusively associated with women who believed they were at risk of HIV in 2012-2017. Women who reported using condoms at last sexual act were also at increased risk of HIV infection, with a population attributable risk of 18% (2002) to 21% (2012-2017). CONCLUSION: There is an urgent need for culturally, socially, and linguistically appropriate prevention and awareness campaigns with realistic, non-confrontational messages.


Asunto(s)
Infecciones por VIH , Conocimientos, Actitudes y Práctica en Salud , Humanos , Femenino , Sudáfrica/epidemiología , Infecciones por VIH/epidemiología , Infecciones por VIH/diagnóstico , Infecciones por VIH/psicología , Adulto , Prevalencia , Persona de Mediana Edad , Adolescente , Adulto Joven , Conducta Sexual/estadística & datos numéricos , Factores de Riesgo , Condones/estadística & datos numéricos , Encuestas Epidemiológicas , Percepción
19.
J Prev (2022) ; 45(3): 339-355, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38416314

RESUMEN

More than 140 million children under five suffered from stunting in 2020. This highlights the ongoing challenge of addressing childhood malnutrition globally. We utilized data from a nationally representative sample of children under five years of age (n = 14,151) who participated in five cycles of the South African National Income Dynamics Study (SA-NIDS) (2008-2017). We estimated the proportion of stunted children attributed to the mothers' anthropometric characteristics and socioeconomic conditions. We also quantified the population-level burden of low-socioeconomic conditions on hunger/food insecurity among pregnant women (n = 22,814) who participated in the nine rounds of the South African General Household Surveys (GHS) (2008-2021). Results from weighted-multivariate logistic regression were incorporated into the population-level impacts of correlates of stunting and low-socioeconomic conditions. The prevalence of stunting declined from 25% in 2008 to 23% in 2017. Mothers' anthropometric measures (underweight/height < 160 cm), marital status, low education, absence of medical insurance and low-socioeconomic conditions were all identified as the most influential risk factors for stunting. Their population-level impacts on stunting increased substantially from 34% (in 2008) to 65% (in 2017). Comprehensive strategies emphasizing enhanced food security, extended breastfeeding, appropriate nutrition, and access to adequate healthcare and education are urgently needed to reduce the burden of food insecurity low-socioeconomic, malnutrition, and its long-term consequences.


Asunto(s)
Trastornos del Crecimiento , Madres , Factores Socioeconómicos , Humanos , Trastornos del Crecimiento/epidemiología , Trastornos del Crecimiento/prevención & control , Sudáfrica/epidemiología , Femenino , Preescolar , Lactante , Masculino , Madres/estadística & datos numéricos , Inseguridad Alimentaria , Adulto , Prevalencia , Embarazo , Factores de Riesgo , Pobreza/estadística & datos numéricos
20.
Sex Transm Infect ; 89(6): 519-22, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23605853

RESUMEN

BACKGROUND AND OBJECTIVES: Trichomonas vaginalis is known to be the most common, curable, sexually transmitted infection among sexually active women and may be associated with the acquisition and transmission of HIV. The purpose of this analysis is to determine the prevalence and incidence of T vaginalis and assess risk factors associated with T vaginalis infection in a cohort of women participating in a clinical trial. METHODS: We analysed data from women participating in a phase III vaginal diaphragm trial conducted in two communities in Durban, South Africa from 2003 to 2006. A total of 3492 women were screened and 1485 women meeting the respective study eligibility criteria were enrolled. T vaginalis infection was determined at the initial screening visit and at quarterly visits among the enrolled women. Sexual behaviour and sociodemographic data were collected as per the study protocol. Combined data were analysed using STATA V.10.0. RESULTS: At baseline, prevalence of infection was 6.5%. The overall incident rate was estimated to be 8.6/100 women-years. Prevalent T vaginalis infection was associated with having a concurrent chlamydial infection and incident infections were associated with increased number of sex partners. CONCLUSIONS: T vaginalis infection was found to be relatively high among this cohort of women. Given the association of this infection with HIV, there is an evident need for T vaginalis screening and treatment in populations at risk for both infections.


Asunto(s)
Tricomoniasis/epidemiología , Trichomonas vaginalis/aislamiento & purificación , Adolescente , Adulto , Ensayos Clínicos como Asunto , Estudios de Cohortes , Demografía , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Conducta Sexual , Factores Socioeconómicos , Sudáfrica/epidemiología , Tricomoniasis/parasitología , Adulto Joven
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