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1.
BMC Womens Health ; 24(1): 462, 2024 Aug 22.
Article de Anglais | MEDLINE | ID: mdl-39174929

RÉSUMÉ

BACKGROUND: HIV incidence remains high in South Africa, with ~ 60% of all new HIV infections among adolescent girls and women (Country factsheets HIV and AIDS Estimates, 2022). Oral pre-exposure prophylaxis (PrEP), approved for HIV prevention in South Africa since 2015, is hampered by low uptake and adherence, particularly among adolescent girls and young women (AGYW). Combining oral PrEP with oral contraceptives could increase PrEP uptake, persistence and address unmet needs for contraception. We investigated the acceptability of a dual prevention pill (DPP), combining oral PrEP and a combined oral contraceptive (COC) for HIV and pregnancy prevention among women in Johannesburg, South Africa. METHODS: Between March-July 2021, we conducted 12 focus group discussions (FGDs) with adolescent girls and women (n = 74) aged 16-40 stratified by ages (16-17, 18-24, 25-40), half of whom were COC users. We explored adolescent girls and women's opinions about the DPP concept, existing HIV and pregnancy prevention options, and input on perceived facilitators and barriers to DPP use. FGDs were conducted in English or isiZulu, using a standardized interview guide. FGDs were audio-recorded, transcribed to English and analyzed using ethnographic content analysis. RESULTS: The majority viewed the DPP favorably as a multipurpose option preventing unplanned pregnancy and HIV. Most saw it as a convenient "two-in-one" solution, requiring one clinic visit for both PrEP and COCs. AGYW were viewed as the most likely to benefit from the DPP due to the likelihood of multiple partners and unplanned sex, possibly preventing school dropout from unplanned pregnancy or HIV acquisition. The DPP was perceived to be more reliable than condoms, especially when condom negotiation is limited. Benefits were also seen by participants in rape cases, protecting against pregnancy and HIV. DPP use barriers included side effect concerns, unsupportive partners and judgmental healthcare providers. CONCLUSIONS/SIGNIFICANCE: The DPP was perceived as acceptable for HIV and pregnancy prevention to AGYW in Johannesburg and its dual indications helpful in supporting improved PrEP uptake and persistence. DPP implementation programs need to consider solutions to potential barriers, like education on DPP benefits, coupled with reliable side effect support and healthcare provider sensitization as part of routine sexual health services to encourage uptake and adherence.


Sujet(s)
Groupes de discussion , Infections à VIH , Prophylaxie pré-exposition , Recherche qualitative , Humains , Femelle , République d'Afrique du Sud , Adolescent , Adulte , Jeune adulte , Infections à VIH/prévention et contrôle , Prophylaxie pré-exposition/méthodes , Grossesse , Contraceptifs oraux combinés/usage thérapeutique , Contraceptifs oraux combinés/administration et posologie
2.
AIDS Behav ; 28(9): 2990-3000, 2024 Sep.
Article de Anglais | MEDLINE | ID: mdl-38852114

RÉSUMÉ

We evaluated correlates of adherence to PrEP, including daily oral tenofovir disoproxil fumarate in combination emtricitabine (oral FTC/TDF) and the monthly dapivirine ring (ring)among adolescent girls and young women (AGYW) in the MTN-034/REACH study. We enrolled 247 AGYW aged 16-21 years in South Africa, Uganda and Zimbabwe (ClinicalTrials.gov: NCT03074786). Participants were randomized to the order of oral FTC/TDF or ring use for 6 months each in a crossover period, followed by a 6-month choice period. We assessed potential adherence correlates-individual, interpersonal, community, study, and product-related factors-quarterly via self-report. We measured biomarkers of adherence monthly; high adherence was defined as > 4 mg dapivirine released from returned rings or intracellular tenofovir diphosphate levels ≥ 700 fmol/punch from dried blood spots (DBS). We tested associations between correlates and objective measures of high adherence using generalized estimating equations. High adherence to oral FTC/TDF was significantly associated with having an older primary partner (p = 0.04), not having exchanged sex in the past 3 months (p = 0.02), and rating oral FTC/TDF as highly acceptable (p = 0.003). High ring adherence was significantly associated with unstable housing (p = 0.01), disclosing ring use to a male family member (p = 0.01), and noting a social benefit from study participation (p = 0.03). All associations were moderate, corresponding to about 6%-10% difference in the proportion with high adherence. In our multinational study, correlates of adherence among African AGYW differed for oral FTC/TDF and the ring, highlighting the benefit of offering multiple PrEP options.


Sujet(s)
Agents antiVIH , Études croisées , Infections à VIH , Adhésion au traitement médicamenteux , Prophylaxie pré-exposition , Humains , Femelle , Adolescent , Prophylaxie pré-exposition/méthodes , Infections à VIH/prévention et contrôle , Adhésion au traitement médicamenteux/statistiques et données numériques , Agents antiVIH/administration et posologie , Jeune adulte , République d'Afrique du Sud , Ouganda , Zimbabwe , Ténofovir/administration et posologie , Ténofovir/usage thérapeutique , Administration par voie orale , Pyrimidines/administration et posologie , Administration par voie vaginale , Emtricitabine/administration et posologie , Dispositifs contraceptifs féminins/statistiques et données numériques
3.
BMJ Open ; 14(3): e075381, 2024 Mar 12.
Article de Anglais | MEDLINE | ID: mdl-38479746

RÉSUMÉ

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women's sexual and reproductive health needs. We will gauge the DPP's acceptability in two cross-over clinical trials. METHODS AND ANALYSIS: PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16-40 years) and Harare, Zimbabwe (n=30, 16-24 years) will be randomised 1:1 to the order of regimens-DPP or two separate tablets-each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024. ETHICS AND DISSEMINATION: PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand's Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences. TRIAL REGISTRATION NUMBERS: NCT04778514, NCT04778527.


Sujet(s)
Contraception , Infections à VIH , Prophylaxie pré-exposition , Femelle , Humains , Agents antiVIH/usage thérapeutique , Études croisées , Infections à VIH/épidémiologie , Infections à VIH/prévention et contrôle , Prophylaxie pré-exposition/méthodes , République d'Afrique du Sud/épidémiologie , Zimbabwe , Essais contrôlés randomisés comme sujet , Adolescent , Jeune adulte , Adulte
5.
Am J Obstet Gynecol ; 230(5): 548.e1-548.e8, 2024 05.
Article de Anglais | MEDLINE | ID: mdl-38295968

RÉSUMÉ

BACKGROUND: The US Food and Drug Administration-approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use. OBJECTIVE: We aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk. STUDY DESIGN: Using data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices. RESULTS: Most participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40-0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26-0.41). Of those who did experience expulsions, most (62%-84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45-2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14-1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29-9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61-3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk. CONCLUSION: Expulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous.


Sujet(s)
Dispositifs contraceptifs féminins , Humains , Femelle , Adulte , Dispositifs contraceptifs féminins/statistiques et données numériques , Facteurs de risque , Grossesse , Jeune adulte , Éthinyloestradiol , Adolescent , Contraceptifs féminins/usage thérapeutique , Modèles logistiques
6.
PLoS One ; 18(8): e0290568, 2023.
Article de Anglais | MEDLINE | ID: mdl-37651432

RÉSUMÉ

BACKGROUND: Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but alternative delivery options are needed to reach more users. Microarray patches (MAPs), a novel drug-delivery system containing micron-scale projections or "microneedles" that deliver drugs via skin, are being developed to deliver long-acting HIV PrEP and as a multipurpose prevention technology to protect from HIV and unintended pregnancy. We explored whether MAP technology could meet user and health system needs in two African countries. METHODS: Researchers in South Africa and Uganda conducted 27 focus group discussions, 76 mock-use exercises, and 31 key informant interviews to explore perceptions about MAPs and specific features such as MAP size, duration of protection, delivery indicator, and health system fit. Participants included young women and men from key populations and vulnerable groups at high risk of HIV and/or unintended pregnancy, including adolescent girls and young women; female sex workers and men who have sex with these women; and men who have sex with men. In Uganda, researchers also recruited young women and men from universities and the community as vulnerable groups. Key stakeholders included health care providers, sexual and reproductive health experts, policymakers, and youth activists. Qualitative data were transcribed, translated, coded, and analyzed to explore perspectives and preferences about MAPs. Survey responses after mock-use in Uganda were tabulated to assess satisfaction with MAP features and highlight areas for additional refinement. RESULTS: All groups expressed interest in MAP technology, reporting perceived advantages over other methods. Most participants preferred the smallest MAP size for ease of use and discreetness. Some would accept a larger MAP if it provided longer protection. Most preferred a protection duration of 1 to 3 months or longer; others preferred 1-week protection. Upper arm and thigh were the most preferred application sites. Up to 30 minutes of wear time was considered acceptable; some wanted longer to ensure the drug was fully delivered. Self-administration was valued by all groups; most preferred initial training by a provider. CONCLUSIONS: Potential users and stakeholders showed strong interest in/acceptance of MAP technology, and their feedback identified key improvements for MAP design. If a MAP containing a high-potency antiretroviral or a MAP containing both an antiretroviral and hormonal contraceptive is developed, these products could improve acceptability/uptake of protection options in sub-Saharan Africa.


Sujet(s)
Infections à VIH , Travailleurs du sexe , Minorités sexuelles , Adolescent , Mâle , Grossesse , Humains , Femelle , République d'Afrique du Sud , Ouganda , Homosexualité masculine , Infections à VIH/prévention et contrôle
7.
PLoS One ; 18(6): e0287525, 2023.
Article de Anglais | MEDLINE | ID: mdl-37352296

RÉSUMÉ

INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. METHODS: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). RESULTS: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. CONCLUSIONS: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs.


Sujet(s)
Agents antiVIH , Infections à VIH , Prophylaxie pré-exposition , Adolescent , Femelle , Humains , Grossesse , Agents antiVIH/usage thérapeutique , Infections à VIH/épidémiologie , Infections à VIH/prévention et contrôle , Infections à VIH/traitement médicamenteux , Prophylaxie pré-exposition/méthodes , République d'Afrique du Sud/épidémiologie , Ouganda/épidémiologie , Zimbabwe/épidémiologie , Jeune adulte
8.
Sci Rep ; 13(1): 245, 2023 01 05.
Article de Anglais | MEDLINE | ID: mdl-36604469

RÉSUMÉ

To identify biomarkers of hormonal contraceptive (HC) use in urine and saliva, we conducted a pilot study with 30 women initiating levonorgestrel (LNG) containing combined oral contraceptives (COCs) or depot medroxyprogesterone acetate (DMPA) (15/group). Based on established COC pharmacokinetics, we collected serum and urine samples before COC ingestion and during Days one and three of use, or before DMPA injection and on Days 21 and 60 post-injection. We used liquid chromatography-tandem mass spectrometry (LC-MS/MS) to measure serum/urine LNG and MPA. LNG was undetectable at baseline (specificity 100%); post ingestion, most urine samples had detectable LNG levels (sensitivity: 80% 6 h post Dose one, 93% 6 h post Dose three). We used a DetectX LNG immunoassay kit and showed 100% sensitivity measuring urine LNG. Urine MPA levels were undetectable in 14/15 women at baseline (specificity 91%); post-injection all urine samples had detectable MPA levels (sensitivity: 100% days 21 and 60). Results suggest urine sampling can be used to identify a biomarker of LNG and MPA use. Based on evidence from other steroidal hormonal studies showing changes affecting the transcriptome profile of saliva at 24 h, we used the same (COC, DMPA) timepoints to collect saliva. We performed transcriptome analysis and detected several differentially expressed genes in DMPA users' saliva on Days 21 and 60 compared to baseline; none among COC users. We plan further research of differential gene expression in saliva as a HC biomarker of DMPA use, and will explore longer periods of COC use and saliva collection times, and application of microRNA sequencing to support using saliva as a COC biomarker.


Sujet(s)
Lévonorgestrel , Spectrométrie de masse en tandem , Femelle , Humains , Chromatographie en phase liquide , Projets pilotes , Acétate de médroxyprogestérone , Contraceptifs oraux combinés
9.
AIDS Educ Prev ; 34(4): 257-271, 2022 08.
Article de Anglais | MEDLINE | ID: mdl-35994578

RÉSUMÉ

Multipurpose prevention technologies (MPT) have been increasingly researched for their dual-purpose preventative properties against HIV and other STIs. The acceptability of PC-1005, a topical MPT candidate, was explored among men and women participating in the MTN-037 Phase I trial at two U.S. sites (Pittsburgh, PA, and Birmingham, AL). We triangulated quantitative and qualitative assessments of the acceptability of three volumes (4 mL, 16 mL, 32 mL) of PC-1005 administered rectally (N = 12; 6 males, 6 females). Participants rated overall gel acceptability on a scale of 1-10, with a median of 7.17 (SD = 2.04) and had positive feelings about all three dose volumes, citing them to be very comfortable or comfortable (dose 1 = 91.7%; dose 2 = 91.7%; dose 3 = 83.3%). High acceptability of and comfort with all three dose volumes shows promise for PC-1005 as an MPT to prevent HIV and STIs, warranting future clinical development.


Sujet(s)
Infections à VIH , Séropositivité VIH , VIH-1 (Virus de l'Immunodéficience Humaine de type 1) , Maladies sexuellement transmissibles , Adulte , Femelle , Infections à VIH/prévention et contrôle , Humains , Mâle , Maladies sexuellement transmissibles/prévention et contrôle
10.
PLoS One ; 17(1): e0261775, 2022.
Article de Anglais | MEDLINE | ID: mdl-35051209

RÉSUMÉ

HIV pre-exposure prophylaxis (PrEP) is dominated by clinical therapeutic antiretroviral (ARV) drugs. Griffithsin (GRFT) is a non-ARV lectin with potent anti-HIV activity. GRFT's preclinical safety, lack of systemic absorption after vaginal administration in animal studies, and lack of cross-resistance with existing ARV drugs prompted its development for topical HIV PrEP. We investigated safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of PC-6500 (0.1% GRFT in a carrageenan (CG) gel) in healthy women after vaginal administration. This randomized, placebo-controlled, parallel group, double-blind first-in-human phase 1 study enrolled healthy, HIV-negative, non-pregnant women aged 24-45 years. In the open label period, all participants (n = 7) received single dose of PC-6500. In the randomized period, participants (n = 13) were instructed to self-administer 14 doses of PC-6500 or its matching CG placebo (PC-535) once daily for 14 days. The primary outcomes were safety and PK after single dose, and then after 14 days of dosing. Exploratory outcomes were GRFT concentrations in cervicovaginal fluids, PD, inflammatory mediators and gene expression in ectocervical biopsies. This trial is registered with ClinicalTrials.gov, number NCT02875119. No significant adverse events were recorded in clinical or laboratory results or histopathological evaluations in cervicovaginal mucosa, and no anti-drug (GRFT) antibodies were detected in serum. No cervicovaginal proinflammatory responses and no changes in the ectocervical transcriptome were evident. Decreased levels of proinflammatory chemokines (CXCL8, CCL5 and CCL20) were observed. GRFT was not detected in plasma. GRFT and GRFT/CG in cervicovaginal lavage samples inhibited HIV and HPV, respectively, in vitro in a dose-dependent fashion. These data suggest GRFT formulated in a CG gel is a safe and promising on-demand multipurpose prevention technology product that warrants further investigation.


Sujet(s)
Carragénane/administration et posologie , Infections à VIH/prévention et contrôle , Infections à papillomavirus/prévention et contrôle , Lectines végétales/administration et posologie , Prophylaxie pré-exposition , Crèmes, mousses et gels vaginaux/administration et posologie , Administration par voie vaginale , Adolescent , Adulte , Méthode en double aveugle , Femelle , VIH-1 (Virus de l'Immunodéficience Humaine de type 1) , Humains , Adulte d'âge moyen , Papillomaviridae
11.
Article de Anglais | MEDLINE | ID: mdl-34318291

RÉSUMÉ

Women of reproductive age need multipurpose prevention technology (MPT) products to address two overlapping health risks: unintended pregnancy and HIV. Currently, condoms are the only available MPT, however male condoms are not within the control of a woman, and the use of female condoms has been limited by low acceptability and cost. Oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet uptake and adherence among women have been low to date. Women globally need more options for HIV and pregnancy prevention. Several MPTs for simultaneous HIV and pregnancy prevention are in various stages of development and clinical testing, although most are many years away from market launch. A dual prevention pill (DPP), a daily oral pill combining oral contraceptives and PrEP, both of which are licensed, approved products in many low- and middle-income countries (LMIC), is likely to be the fastest route to getting an MPT product into the hands of women. The DPP is one option that could enhance method choice, particularly for women who are already using oral contraceptives. By leveraging the oral contraceptive market and reaching women currently using condoms or with an unmet need for contraception, the DPP has the potential to increase the uptake of PrEP. The successful rollout of the DPP will require careful consideration of user-, provider-, and product-centered factors during product development and introduction. Early attention to these interrelated factors can help ensure that the DPP has the ideal characteristics for maximum product acceptability, that effective and quality services are designed and implemented, and that users can make informed choices, demand the product, and use it effectively. The proposed framework outlines key considerations for the effective development and introduction of the DPP, which could also facilitate integration models for future MPTs.

12.
BMJ Sex Reprod Health ; 47(3): 166-172, 2021 07.
Article de Anglais | MEDLINE | ID: mdl-32737137

RÉSUMÉ

INTRODUCTION: Uptake of oral pre-exposure prophylaxis (PrEP) remains low. The objective of this analysis was to estimate the potential market size in priority sub-Saharan African countries for a 28-day dual prevention pill (DPP) regimen containing the active pharmaceutical ingredients in oral PrEP and oral contraceptive pills (OCPs) for the prevention of HIV and unintended pregnancy. METHODS: We selected 15 countries in sub-Saharan Africa for analysis. Population estimates were based on United Nations Population Division data from 2017. Low, medium and high rates (range 0.25% to 25%) of estimated conversion from current contraceptive method to the DPP were applied by country based on HIV prevalence (≥10% vs <10%), current contraceptive method (OCP, condom or unmet need for contraception) and age group (15-24 or 25-49 years). RESULTS: In these 15 countries, between 250 000 and 1.25 million women could switch from their current contraceptive method to the DPP. Given that current PrEP use in the 15 countries combined is estimated to be 113 250 (women and men), the most conservative market size estimate would more than double the number of women currently using PrEP. CONCLUSIONS: By leveraging the existing market for OCPs and assuming modest conversion from condom users and women with an unmet need for contraception, the DPP could lead to a 2- to 10-fold increase in PrEP usage in these 15 sub-Saharan African countries, expanding the broader public health benefit of this proven HIV prevention strategy.


Sujet(s)
Prophylaxie pré-exposition , Adulte , Préservatifs masculins , Contraception , Femelle , Humains , Mâle , Adulte d'âge moyen , Grossesse , Grossesse non planifiée , Rapports sexuels protégés
13.
AIDS ; 34 Suppl 1: S5-S18, 2020 09 01.
Article de Anglais | MEDLINE | ID: mdl-32881790

RÉSUMÉ

OBJECTIVE(S): To describe the process of updating the People Living with HIV (PLHIV) Stigma Index (Stigma Index) to reflect current global treatment guidelines and to better measure intersecting stigmas and resilience. DESIGN: Through an iterative process driven by PLHIV, the Stigma Index was revised, pretested, and formally evaluated in three cross-sectional studies. METHODS: Between March and October 2017, 1153 surveys (n = 377, Cameroon; n = 390, Senegal; n = 391, Uganda) were conducted with PLHIV at least 18 years old who had known their status for at least 1 year. PLHIV interviewers administered the survey on tablet computers or mobile phones to a diverse group of purposively sampled respondents recruited through PLHIV networks, community-based organizations, HIV clinics, and snowball sampling. Sixty respondents participated in cognitive interviews (20 per country) to assess if questions were understood as intended, and eight focus groups (Uganda only) assessed relevance of the survey, overall. RESULTS: The Stigma Index 2.0 performed well and was relevant to PLHIV in all three countries. HIV-related stigma was experienced by more than one-third of respondents, including in HIV care settings. High rates of stigma experienced by key populations (such as MSM and sex workers) impeded access to HIV services. Many PLHIV also demonstrated resilience per the new PLHIV Resilience Scale. CONCLUSION: The Stigma Index 2.0 is now more relevant to the current context of the HIV/AIDS epidemic and response. Results will be critical for addressing gaps in program design and policies that must be overcome to support PLHIV engaging in services, adhering to antiretroviral therapy, being virally suppressed, and leading healthy, stigma-free lives.


Sujet(s)
Infections à VIH/psychologie , Psychométrie/statistiques et données numériques , Résilience psychologique , Stigmate social , Enquêtes et questionnaires/normes , Adolescent , Adulte , Cameroun , Études transversales , Infections à VIH/diagnostic , Infections à VIH/traitement médicamenteux , Accessibilité des services de santé , Homosexualité masculine , Humains , Entretiens comme sujet , Mâle , Adulte d'âge moyen , Recherche qualitative , Reproductibilité des résultats , Sénégal , Discrimination sociale/psychologie , Ouganda , Jeune adulte
14.
AIDS ; 34 Suppl 1: S19-S31, 2020 09 01.
Article de Anglais | MEDLINE | ID: mdl-32881791

RÉSUMÉ

OBJECTIVE: To inform efforts to promote greater resilience among people living with HIV (PLHIV), we examined associations between resilience and factors at the individual, interpersonal and structural/policy levels in three countries. DESIGN: Data come from the PLHIV Stigma Index 2.0, a cross-sectional survey with PLHIV, implemented from 2017 to 2019 in Cambodia (n = 1207), the Dominican Republic (n = 891), and Uganda (n = 391). METHODS: Hierarchical multiple regression was used to assess associations between resilience and factors at the individual/interpersonal/structural-policy levels, controlling for potential confounders. Resilience was measured by the previously tested PLHIV Resilience Scale. RESULTS: About 60% of respondents were women; mean time since HIV diagnosis was 11 years in Cambodia and seven in the Dominican Republic /Uganda. Resilience varied substantially across the six province/districts per country (all p < 0.001). In multivariable analyses, higher resilience was associated with lower internalized stigma (all three countries), no experience of human rights abuses (Dominican Republic), no food/housing insecurity (Uganda), and greater community awareness of legal protections for PLHIV (Cambodia and Dominican Republic). HIV-related enacted stigma (i.e., discrimination) in the community was associated with lower resilience in Cambodia, but higher resilience in the Dominican Republic. The set of structural/policy-level factors in Cambodia and the Dominican Republic, and individual-level in Uganda, explained the most variance in resilience. CONCLUSION: Factors at multiple levels affect whether PLHIV in Cambodia, the Dominican Republic, and Uganda report resilience. Multilevel interventions are required to promote resilience among PLHIV, and should incorporate efforts to reduce internalized stigma and promote supportive structural/legal environments including broader awareness of legal protections for PLHIV.


Sujet(s)
, Infections à VIH/psychologie , Qualité de vie/psychologie , Résilience psychologique , Discrimination sociale/psychologie , Stigmate social , Enquêtes et questionnaires/normes , Adulte , Cambodge , Études transversales , République dominicaine , Femelle , Accessibilité des services de santé , Droits de l'homme , Humains , Adulte d'âge moyen , Ouganda , Jeune adulte
15.
AIDS ; 34 Suppl 1: S33-S41, 2020 09 01.
Article de Anglais | MEDLINE | ID: mdl-32881792

RÉSUMÉ

OBJECTIVE: Measuring internalized stigma is critical to understanding its impact on the health and quality of life of people living with HIV (PLHIV). The aim of this study was to assess the performance of the Internalized AIDS-Related Stigma Scale (IA-RSS). DESIGN: Secondary analysis of the six-item IA-RSS was conducted using data from four cross-sectional surveys implemented in Cambodia (n = 1207), the Dominican Republic (n = 891), Uganda (n = 391) and Tanzania (n = 529) between 2018 and 2019. METHODS: IA-RSS scale item distribution was described. Multivariate regression models measured correlations between the IA-RSS and depression, antiretroviral therapy (ART) use and viral suppression. Confirmatory factor analysis assessed IA-RSS reliability and performance through analysis of standardized factor loadings and conditional probabilities of scale items. Analysis of qualitative interviews with PLHIV explored acceptability of IA-RSS item content. RESULTS: Mean IA-RSS scores (possible 0-6) ranged from 2.06 (Uganda) to 3.84 (Cambodia), and internal consistency was more than 0.70 in each country (Kuder-Richardson 20), ranging from 0.71 to 0.83. Higher IA-RSS scores were strongly correlated with depression in (P < 0.001 in all countries), and inversely associated with current ART use (Dominican Republic and Tanzania) and self-reported viral suppression (Uganda and Tanzania). Confirmatory factor analysis showed good model fit (all CFI ≥ 0.950), but also that the IA-RSS may summarize two domains related to HIV status disclosure (two items) and PLHIV feelings about themselves (four items). CONCLUSION: Strong performance across countries supports continued use of the IA-RSS. Further study is needed to explore potential item refinements and to better understand the relationship between internalized stigma and HIV treatment outcomes.


Sujet(s)
Agents antiVIH/usage thérapeutique , Infections à VIH , Qualité de vie/psychologie , Discrimination sociale/psychologie , Stigmate social , Enquêtes et questionnaires/normes , Adulte , Thérapie antirétrovirale hautement active , Cambodge , Études de cohortes , Études transversales , République dominicaine , Femelle , Infections à VIH/traitement médicamenteux , Infections à VIH/psychologie , Humains , Mâle , Adulte d'âge moyen , Reproductibilité des résultats , Tanzanie , Ouganda
17.
J Adolesc Health ; 60(2S2): S35-S44, 2017 Feb.
Article de Anglais | MEDLINE | ID: mdl-28109339

RÉSUMÉ

PURPOSE: Working with health providers to reduce HIV stigma in the healthcare setting is an important strategy to improve service utilization and quality of care, especially for young people who are sexually active before marriage, are sexual minorities, or who sell sex. A stigma reduction training program for health providers in Bangladesh was evaluated. METHODS: A cohort of 300 healthcare providers were given a self-administered questionnaire, then attended a 2-day HIV and sexual and reproductive health and rights training (including a 90-minute session on stigma issues). Six months later, the cohort repeated the survey and participated in a 1-day supplemental training on stigma, which included reflection on personal values and negative impacts of stigma. A third survey was administered 6 months later. A cross-sectional survey of clients age 15-24 years was implemented before and after the second stigma training to assess client satisfaction with services. RESULTS: Provider agreement that people living with HIV should be ashamed of themselves decreased substantially (35.3%-19.7%-16.3%; p < .001), as did agreement that sexually active young people (50.3%-36.0%-21.7%; p < .001) and men who have sex with men (49.3%-38.0%-24.0%; p < .001) engage in "immoral behavior." Young clients reported improvement in overall satisfaction with services after the stigma trainings (63.5%-97.6%; p < .001). CONCLUSIONS: This study indicates that a targeted stigma reduction intervention can rapidly improve provider attitudes and increase service satisfaction among young people. More funding to scale up these interventions is needed.


Sujet(s)
Attitude du personnel soignant , Satisfaction des patients , Droits procréatifs/enseignement et éducation , Stigmate social , Stéréotypes , Adolescent , Adulte , Bangladesh , Études transversales , Femelle , Infections à VIH/psychologie , Humains , Mâle , Prostitution/statistiques et données numériques , Comportement sexuel/psychologie , Enquêtes et questionnaires , Jeune adulte
18.
Antimicrob Agents Chemother ; 60(9): 5459-66, 2016 09.
Article de Anglais | MEDLINE | ID: mdl-27381393

RÉSUMÉ

Our recent phase 1 trial demonstrated that PC-1005 gel containing 50 µM MIV-150, 14 mM zinc acetate dihydrate, and carrageenan (CG) applied daily vaginally for 14 days is safe and well tolerated. Importantly, cervicovaginal lavage fluid samples (CVLs) collected 4 or 24 h after the last gel application inhibited HIV-1 and human papillomavirus (HPV) in cell-based assays in a dose-dependent manner (MIV-150 for HIV-1 and CG for HPV). Herein we aimed to determine the anti-HIV and anti-herpes simplex virus 2 (anti-HSV-2) activity of PC-1005 in human cervical explants after in vitro exposure to the gel and to CVLs from participants in the phase 1 trial. Single HIV-1BaL infection and HIV-1BaL-HSV-2 coinfection explant models were utilized. Coinfection with HSV-2 enhanced tissue HIV-1BaL infection. In vitro exposure to PC-1005 protected cervical mucosa against HIV-1BaL (up to a 1:300 dilution) in single-challenge and cochallenge models. CG gel (PC-525) provided some barrier effect against HIV-1BaL at the 1:100 dilution in a single-challenge model but not in the cochallenge model. Both PC-1005 and PC-525 at the 1:100 dilution inhibited HSV-2 infection, pointing to a CG-mediated protection. MIV-150 and CG in CVLs inhibited HIV (single-challenge or cochallenge models) and HSV-2 infections in explants in a dose-dependent manner (P < 0.05). Stronger inhibition of HIV-1 infection by CVLs collected 4 h after the last gel administration was observed compared to infection detected in the presence of baseline CVLs. The anti-HIV and anti-HSV-2 activity of PC-1005 gel in vitro and CVLs in human ectocervical explants supports the further development of PC-1005 gel as a broad-spectrum on-demand microbicide.


Sujet(s)
Anti-infectieux/pharmacologie , Liquides biologiques/virologie , Infections à VIH/traitement médicamenteux , Herpès génital/traitement médicamenteux , Muqueuse/virologie , Vagin/effets des médicaments et des substances chimiques , Administration par voie vaginale , Liquides biologiques/effets des médicaments et des substances chimiques , Co-infection/traitement médicamenteux , Co-infection/virologie , Femelle , Gels/pharmacologie , Infections à VIH/virologie , Transcriptase inverse du VIH/pharmacologie , VIH-1 (Virus de l'Immunodéficience Humaine de type 1)/effets des médicaments et des substances chimiques , Herpès génital/virologie , Herpèsvirus humain de type 2/effets des médicaments et des substances chimiques , Humains , Muqueuse/effets des médicaments et des substances chimiques , Pyridines/pharmacologie , Urée/analogues et dérivés , Urée/pharmacologie , Vagin/virologie , Acétate de zinc/pharmacologie
19.
J Acquir Immune Defic Syndr ; 73(5): 489-496, 2016 Dec 15.
Article de Anglais | MEDLINE | ID: mdl-27437826

RÉSUMÉ

OBJECTIVE: To evaluate the safety and pharmacokinetics of MIV-150 and zinc acetate in a carrageenan gel (PC-1005). Acceptability, adherence, and pharmacodynamics were also explored. DESIGN: A 3-day open-label safety run-in (n = 5) preceded a placebo-controlled, double-blind trial in healthy, HIV-negative, abstinent women randomized (4:1) to vaginally apply 4 mL of PC-1005 or placebo once daily for 14 days. METHODS: Assessments included physical examinations, safety labs, colposcopy, biopsies, cervicovaginal lavages (CVLs), and behavioral questionnaires. MIV-150 (plasma, CVL, tissue), zinc (plasma, CVL), and carrageenan (CVL) concentrations were determined with LC-MS/MS, ICP-MS, and ELISA, respectively. CVL antiviral activity was measured using cell-based assays. Safety, acceptability, and adherence were analyzed descriptively. Pharmacokinetic parameters were calculated using noncompartmental techniques and actual sampling times. CVL antiviral EC50 values were calculated using a dose-response inhibition analysis. RESULTS: Participants (n = 20) ranged from 19-44 years old; 52% were black or African American. Among those completing the trial (13/17, PC-1005; 3/3, placebo), 11/17 reported liking the gel overall; 7 recommended reducing the volume. Adverse events, which were primarily mild and/or unrelated, were comparable between groups. Low systemic MIV-150 levels were observed, without accumulation. Plasma zinc levels were unchanged from baseline. Seven of seven CVLs collected 4-hour postdose demonstrated antiviral (HIV, human papillomavirus) activity. High baseline CVL anti-herpes-simplex virus type-2 (HSV-2) activity precluded assessment of postdose activity. CONCLUSIONS: PC-1005 used vaginally for 14 days was well tolerated. Low systemic levels of MIV-150 were observed. Plasma zinc levels were unchanged. Postdose CVLs had anti-HIV and anti-human papillomavirus activity. These data warrant further development of PC-1005 for HIV and sexually transmitted infection prevention.


Sujet(s)
Antiviraux/administration et posologie , Carragénane/administration et posologie , Gels/administration et posologie , Prophylaxie pré-exposition/méthodes , Pyridines/administration et posologie , Maladies sexuellement transmissibles virales/prévention et contrôle , Urée/analogues et dérivés , Acétate de zinc/administration et posologie , Administration par voie vaginale , Adulte , Antiviraux/effets indésirables , Antiviraux/pharmacocinétique , Carragénane/effets indésirables , Carragénane/pharmacocinétique , Chromatographie en phase liquide , Méthode en double aveugle , Femelle , Gels/effets indésirables , Humains , Adhésion au traitement médicamenteux , Acceptation des soins par les patients , Placebo/administration et posologie , Pyridines/effets indésirables , Pyridines/pharmacocinétique , Spectrométrie de masse en tandem , Urée/administration et posologie , Urée/effets indésirables , Urée/pharmacocinétique , Jeune adulte , Acétate de zinc/effets indésirables , Acétate de zinc/pharmacocinétique
20.
AIDS Behav ; 20(11): 2565-2577, 2016 11.
Article de Anglais | MEDLINE | ID: mdl-26204987

RÉSUMÉ

A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women's risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in ≥85 % of sex acts). Women who reported ≥1 vaginal sex act, returned ≥1 opened applicator, and had ≥1 conclusive post-enrollment HIV test (N = 5990) were included. Adherence was estimated as the ratio of average weekly applicator insertions (based on a dye stain assay indicating vaginal insertion)/average weekly sex acts (by self-report). Multivariate logistic regression modeling indicated that coital frequency, site, contraception, and partner age difference had a significant impact on adherence. Women reporting >1 and ≤2 vaginal sex acts per week, on average, were half as likely to be adherent as those reporting 1 vaginal sex act per week or less [adjusted odds ratio (AOR): 0.48; 95 % CI 0.38-0.61]; women from the Western Cape had one-third the odds of being adherent compared to women from KZN (AOR: 0.31; 95 % CI 0.23-0.41); compared to women using injectable contraception, women using any other or no method were more likely to be adherent (AOR: 1.30; 95 % CI 1.04-1.63); and women who had a larger age gap from their partners were more likely to be adherent (AOR: 1.03; 95 % CI 1.01-1.05; p = 0.001). Despite low adherence, overall, 13 % of participants achieved nearly perfect adherence, indicating a potential niche for a coitally dependent microbicide. More research is needed on the impact of sexual patterns and HIV risk perception on product acceptability and adherence to improve counseling in ongoing trials and when products are eventually introduced.


Sujet(s)
Anti-infectieux/administration et posologie , Infections à VIH/prévention et contrôle , Adhésion au traitement médicamenteux , Comportement sexuel , Crèmes, mousses et gels vaginaux/administration et posologie , Adolescent , Adulte , Anti-infectieux/effets indésirables , Coït , Femelle , Infections à VIH/diagnostic , Infections à VIH/épidémiologie , Humains , Incidence , Modèles logistiques , Adulte d'âge moyen , Analyse multifactorielle , République d'Afrique du Sud/épidémiologie , Crèmes, mousses et gels vaginaux/effets indésirables , Jeune adulte
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