Inconsistent Counselor Fidelity in Delivering an Evidence-Based Adherence Intervention During a PrEP Trial.

Evidence-based adherence counseling interventions must be delivered with fidelity to ensure that their effectiveness is retained, but little is known regarding how counselors in biomedical HIV trials deliver these interventions. Forty-two counselors from the MTN-025/HOPE Study, which was conducted in 14 sites in sub-Saharan Africa, participated. They completed a quantitative assessment and consented for their HOPE counseling session ratings to be analyzed. Twenty-two (52%) self-identified as research nurses and 20 (48%) as counselors. Of 928 session ratings, 609 (66%) were classified as Good, 188 (20%) as Fair, and 131 (14%) as Poor, based on pre-established criteria. Overall mean ratings for session tasks and global components (each rated from 1 to 5) were 4.12 (SD = 0.45; range 2.46-4.73) and 4.02 (SD = 0.64; range 1.75-4.79), respectively. Twenty-six (62%) counselors attained Good or Fair ratings on at least 85% of their sessions, but 33% of counselors had more than 25% of their sessions rated as Poor; three counselors (7%) never met criteria for a Good session. Even after extensive training, counselors' fidelity to the intervention varied. Our findings highlight the value of fidelity monitoring using session audio-recordings, the importance of ongoing coaching and support, and the need to plan for counselors with consistently poor fidelity.

RESUMEN: Las intervenciones de consejería de adherencia basadas en la evidencia deben ser realizadas con fidelidad para asegurar que retengan su efectividad, pero se sabe poco sobre cómo los consejeros en ensayos biomédicos de VIH realizan estas intervenciones. Cuarenta y dos consejeros participaron del Estudio MTN-025/HOPE, el cual se llevó a cabo en 14 sitios en África subsahariana. Completaron un cuestionario cuantitativo y dieron su consentimiento para el análisis de las calificaciones de sus sesiones de consejería para HOPE. Veintidós (52%) se identificaron como enfermeras investigadoras y 20 (48%) como consejeros. De 928 sesiones calificadas, 609 (66%) fueron clasificadas como Buenas, 188 (20%) como Suficientes, y 131 (14%) como Mediocres, basado en criterios preestablecidos. Las calificaciones promedias de las tareas de las sesiones y de los componentes globales (calificados de 1 a 5) fueron de 4.12 (SD = 0.45; rango 2.46­4.73) y de 4.02 (SD = 0.64; rango 1.75­4.79), respectivamente. Veintiséis (62%) consejeros lograron calificaciones Buenas o Suficientes en al menos el 85% de sus sesiones, pero para el 33% de los consejeros, más del 25% de sus sesiones fueron calificadas como Mediocres; tres consejeros (7%) nunca cumplieron con los criterios de una Buena sesión. Aún después de una capacitación intensiva, la fidelidad a la intervención variaba. Nuestros hallazgos destacan el valor de monitorear para la fidelidad usando audio-grabaciones de las sesiones, la importancia de la instrucción y el apoyo continuo, y la necesidad de planear qué medidas tomar cuando hay consejeros que no son fieles a la intervención.

Disclosure of microbicide gel use to sexual partners: influence on adherence in the CAPRISA 004 trial.

Young women in sub-Saharan Africa are disproportionately affected by HIV, making the development of women initiated and controlled methods of prevention, including microbicides, a priority. Adherence is pivotal to microbicide efficacy and partner related factors are known to impact adherence. An analysis of disclosure of gel use to sexual partners and adherence in CAPRISA 004 women was conducted to better understand this relationship. Partner disclosure was significantly associated with a modest 4.2 % increased adherence (71.0 vs. 66.8 %, p = 0.03). Most women rated the experience of disclosure as positive, despite 6.7 % of partners expressing a negative reaction.Participants who disclosed were more likely to reside with their regular partner (14.4 vs. 8.4 %; p = 0.01) and reported consistent condom use at baseline (32.9 vs. 20.9 %; p < 0.01). Partner disclosure needs to be better understood as a potential facilitator or barrier to microbicide adherence.

Adherence in the CAPRISA 004 tenofovir gel microbicide trial.

High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir gel trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17,031 monthly visits. On average women reported five sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2 % compared to the 82.0 % self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials.

Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.

High adherence is important in microbicide trials, but no adherence interventions to date have demonstrated empiric improvements in microbicide adherence or effectiveness. Approximately midway during the CAPRISA 004 trial, we implemented a novel adherence intervention (Adherence Support Program-ASP), based on an Information-Motivation-Behavioral Skills model and incorporating a Motivational Interviewing approach. We assessed the impact of the ASP on adherence and tenofovir gel effectiveness using a before-and-after comparison. Of the 889 women in the trial, 774 contributed 486.1 women-years of follow-up pre-ASP and 828 contributed 845.7 women-years of follow-up post-ASP. Median adherence rose from 53.6 % pre-ASP to 66.5 % post-ASP. Detectable tenofovir levels increased from 40.6 % pre-ASP to 62.5 % post-ASP in 64 women who had paired tenofovir drug samples. Gel effectiveness improved post-ASP; HIV incidence in the tenofovir gel arm was 24 % lower pre-ASP compared to 47 % lower post-ASP. Following implementation of the ASP, microbicide adherence improved with a concomitant increase in the effectiveness of tenofovir gel.

HIV incidence in young girls in KwaZulu-Natal, South Africa--public health imperative for their inclusion in HIV biomedical intervention trials.

Young women are particularly vulnerable for acquiring HIV yet they are often excluded from clinical trials testing new biomedical intervention. We assessed the HIV incidence and feasibility of enrolling a cohort of young women for potential participation in future clinical trials. Between March 2004 and May 2007, 594 HIV uninfected 14-30 year old women were enrolled into a longitudinal HIV risk reduction study in KwaZulu-Natal, South Africa. The overall HIV prevalence at screening in young girls below the age of 18 years was 27.6 % compared to 52.0 % in the women above 18 years, p < 0.001. HIV incidence was 4.7 [95 % Confidence interval (CI) 1.5-10.9) and 6.9 (95 % CI 4.8-9.6)/100 women years (wy), p = 0.42 and pregnancy rates were 23.7 (95 % CI 14.9-35.9) and 16.4 (95 % CI 12.9-20.6)/100 wy, p = 0.29, in the women below and above 18 years respectively. Retention was similar in both groups (71.0 vs. 71.5 %, p = 0.90). This study demonstrates that the inclusion of young girls between the ages of 14 and 17 years in longitudinal studies is feasible and their inclusion in clinical trials would maintain scientific integrity and power of the study.

Culturally-Based Challenges to and Recommendations for Delivering Adherence Counseling in a Multicultural Biomedical HIV Prevention Trial in Four African Countries.

Research is needed to identify how to effectively tailor evidence-based interventions across cultures with limited resources, particularly for behavioral components in large HIV prevention trials. Through surveys and interviews with counselors of sub-Saharan African women during an open-label microbicide trial (MTN-025), we examined language, education, and cultural barriers in delivering a motivational interviewing-based adherence counseling intervention (i.e., Options Counseling). Counselors encountered an array of barriers, most prominently that participants struggled to comprehend culturally incongruent pictorial guides, such as traffic light images, and to uphold product use when primary partners disapproved. Overwhelmingly, counselors cited the intervention's inherent flexibility as an asset; it encouraged them to tailor language and examples to be more culturally relevant to participants. Future resource-conscious researchers may preemptively offset similar barriers by consulting with communities during intervention development. Similarly, affording counselors flexibility while delivering the chosen intervention may enable them to troubleshoot barriers that arise on the ground.

Stabilizing HIV prevalence masks high HIV incidence rates amongst rural and urban women in KwaZulu-Natal, South Africa.

BACKGROUND: In mature generalized human immunodeficiency virus (HIV) epidemics, as survival from accessing antiretroviral treatment (ART) increases, HIV prevalence data may be suboptimal and difficult to interpret without HIV incidence rates. OBJECTIVE: To determine the HIV incidence rate among rural and urban women in KwaZulu-Natal, South Africa. METHODS: We conducted a prospective cohort study from March 2004 to May 2007. Volunteers were recruited from a rural family-planning clinic and an urban clinic for sexually transmitted infections. Consenting, HIV-uninfected women aged 14-30 years were enrolled. Demographic, clinical, sexual and behavioural data were collected using standardized questionnaires with HIV risk reduction counselling and HIV testing. Pelvic examinations were completed at quarterly visits. RESULTS: The HIV prevalence at screening was 35.7% [95% confidence interval (CI) 32.7-38.8] amongst rural women and 59.3% (95% CI 56.5-62.0) amongst urban women. A total of 594/2240 (26.5%) enrolled women contributed to 602 person-years (PYs) of follow-up. The median age was 22 years [inter-quartile range 18-23 years]. HIV incidence rate was 6.5/100 PY (95% CI 4.4-9.2) amongst rural women and 6.4/100 PY (95% CI 2.6-13.2) amongst urban women. HIV incidence rate of 17.2/100 PY (95% CI 2.1-62.2) was highest amongst urban women <20 years of age and 10.2/100 PY (95% CI 4.1-20.9) amongst rural women ≥ 25 years of age. CONCLUSION: HIV incidence rates are devastatingly high in young women in rural and urban KwaZulu-Natal, despite reports of stabilized HIV prevalence observed in current surveillance data. The diffuse nature of the HIV epidemic underscores the urgent need to enhance HIV prevention and treatment modalities.