Acceptability of a Randomized Trial of Anti-depressant Medication or Interpersonal Therapy for Treatment of Perinatal Depression in Women with HIV.

Postpartum depression (PPD) affects nearly 20% of postpartum women in Sub-Saharan Africa (SSA), where HIV prevalence is high. Depression is associated with worse HIV outcomes in non-pregnant adults and mental health disorders may worsen HIV outcomes for postpartum women and their infants. PPD is effectively treated with psychosocial or pharmacologic interventions; however, few studies have evaluated the acceptability of treatment modalities in SSA. We analyzed interviews with 23 postpartum women with HIV to assess the acceptability of two depression treatments provided in the context of a randomized trial. Most participants expressed acceptability of treatment randomization and study visit procedures. Participants shared perceptions of high treatment efficacy of their assigned intervention. They reported ongoing HIV and mental health stigma in their communities and emphasized the importance of social support from clinic staff. Our findings suggest a full-scale trial of PPD treatment will be acceptable among women with HIV in Zambia.

An Internship Approach to Strengthen the Pathway for Historically Underrepresented Groups in Health Sciences Research: The North Carolina Diversity and Inclusion Pathway Program.

BACKGROUND: To increase engagement of historically underrepresented groups in health sciences research, we created the North Carolina Diversity and Inclusion Pathway Program (NC-DIPP). This year-long, paid internship provides undergraduate and graduate students from 2 historically Black colleges and universities an opportunity to gain real-world experience under the mentorship of expert faculty. METHODS: To evaluate the early experiences with the NC-DIPP program, we conducted semi-structured interviews with interns and program leaders. Faculty mentors completed an online questionnaire to describe their experiences to date. A thematic approach was used to analyze the findings. RESULTS: In March-April 2023, 7 of 8 interns (88%), 6 of 11 mentors (54%), and 4 of 4 program leaders (100%) participated in various evaluation components. Overall, respondents agreed about the importance of programs like NC-DIPP, which further engage historically underrepresented groups in the health sciences. Interns had positive feedback about the internship, including real-world work experience, connections to experienced mentors, and early career planning. On a scale of 1 (poor) to 10 (excellent), interns rated their experience as a median of 8.3 (range: 4.5-10.0). Mentors had favorable but slightly lower scores (median: 7.0, range: 5.0-8.0). Areas for improvement were noted, including clearer expectations, improved logistical support, and central engagement of interns across projects. CONCLUSIONS: This early evaluation of NC-DIPP was generally favorable across all stakeholder groups. By providing a long-term experience in health science research, such programs can contribute to work experience, career planning, and professional networking.

Corrigendum to "HIV remission trial investigators' attitudes towards risk and risk mitigation in trials that include treatment interruption" [J Virus Erad 9 (2) (June 2023) 100331].

[This corrects the article DOI: 10.1016/j.jve.2023.100331.].

HIV remission trial investigators' attitudes towards risk and risk mitigation in trials that include treatment interruption.

Early-phase HIV remission ("cure") trials aim to test interventions developed to eradicate HIV or to sustainably control HIV without antiretroviral treatment (ART). Many remission trials include analytic treatment interruption (ATI) to evaluate interventions, which increases the risk to participants and their sexual partners. We conducted an online questionnaire of international HIV remission trial investigators and other study team members to assess their expectations regarding the time to achieve long-term control of HIV replication without treatment (functional cure) or complete eradication of replication-competent HIV virus (sterilizing cure); attitudes toward HIV remission research and the feasibility, acceptability, and efficacy of six HIV transmission risk mitigation strategies during trials with ATI of fixed duration. Nearly half of respondents (47%) reported expecting a functional cure for HIV to be achieved in 5-10 years, and one-third (35%) reported 10-20 years for a sterilizing cure to be achieved. On a scale of -3 to 3, mean scores indicated greater respondent concern about the risk of HIV transmission to partners during ATI (Time to rebound Mean: 0.4 and Fixed duration Mean: 11), compared to participant health risks from ATI (Time to Rebound Mean: -.9 and Fixed duration Mean: 0.0). With regard to feasibility, acceptability, and efficacy respectively, mitigation efforts rated positively included: requiring counseling for potential participants (Means: 2.3; 2.1; and 1.1), providing partner referrals for PrEP (Means: 1.3; 1.3; 1.5), providing pre-exposure proxylaxis directly to partners (Means: 1.0; 1.5; 1.6), and monitoring participants for new sexually transmitted disease acquisition (Means: 1.9; 1.4; 1.0). Respondents were less positive about requiring that participants' sexual partner(s) participate in risk counseling or limiting participation to those who commit to abstaining from sex during the entire ATI period. Our study demonstrates that HIV remission trial investigators and study team members are concerned about the risk of transmission to sexual partners during ATI. Separating the assessment of risk mitigation strategies for transmission risk into feasibility, acceptability, and efficacy allows the discovery of strategies that may best achieve all three outcomes. Additional research is needed to compare these more fine-grained assessments with views held by other investigators, people living with HIV, and trial participants.

"The role of case management in HIV treatment adherence: HPTN 078".

Adherence to care and antiretroviral therapy is challenging, especially for people living with HIV (PLWH) with additional co-occurring risk factors. Case management interventions, including motivational interviewing (MI), show promise to improve HIV treatment adherence, but few studies have examined how such interventions are delivered to or experienced by PLWH who have been reengaged in care. We conducted qualitative interviews with six case managers and 110 PLWH exiting from a randomized study (HPTN 078) who received a MI-based case management intervention in addition to standard patient-navigation services, or standard services only. Our study provided greater insight into the main findings from HPTN 078, including an in-depth description of the multiple barriers to adherence faced by this largely "out-of-care" population, as well as a more nuanced understanding of the benefits and challenges of implementing MI. A blend of MI plus more intensive interventions may be needed for PLWH facing multiple structural barriers.

Cognitive testing of an instrument to evaluate acceptability and use of pre-exposure prophylaxis products among women.

Given the range of pre-exposure prophylaxis (PrEP) products currently being tested to prevent HIV in women, a standardized Acceptability and Use of PrEP Products Among Women Tool may facilitate comparisons of product acceptability and use across different geographies, trials, and users. We conducted three rounds of cognitive interviewing over 2 months in 2016, with 28 South African women who had experience participating in a range of PrEP product trials. The final instrument contained 41 items, including five new items that improved construct validity and 22 items modified for clarity. Changes were made due to unclear wording, difficulty answering, participant embarrassment, low response variability, and administrative formatting. Cognitive interviewing provided a means to address issues that would have inhibited this tool's ability to accurately collect data otherwise. This rapid, low-cost study provided valuable insight into participants' understanding of questions and demonstrated the utility of cognitive interviewing in international clinical trials.

Corrigendum: Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

[This corrects the article on p. 47 in vol. 5, PMID: 28349049.].

Attitudes and perceptions towards novel objective measures of ARV-based vaginal ring use: Results from a global stakeholder survey.

Results of recent microbicide and pre-exposure prophylaxis clinical trials have shown adherence to be a significant challenge with new HIV prevention technologies. As the vaginal ring containing dapivirine moves into two open label follow-on studies (HOPE/MTN-025 and DREAM) and other antiretroviral-based and multi-purpose prevention technology ring products advance through the development pipeline, there is a need for more accurate and reliable measures of adherence to microbicide ring products. We previously conducted a comprehensive landscape analysis to identify new technologies that could be applied to adherence measurement of vaginal rings containing antiretrovirals. To explore attitudes and perceptions towards the approaches that we identified, we conducted a survey of stakeholders with experience and expertise in microbicide and HIV prevention clinical trials. From May to July 2015 an electronic survey was distributed via email to 894 stakeholders; a total of 206 eligible individuals responded to at least one question and were included in the data analysis. Survey respondents were presented with various objective measures and asked about their perceived acceptability to trial participants, feasibility of implementation by study staff, usefulness for measuring adherence and ethical concerns. Methods that require no additional input from the participant and require no modifications to the existing ring product (i.e., measurement of residual drug or excipient, or a vaginal analyte that enters the ring) were viewed as being more acceptable to trial participants and more feasible to implement in the field. Respondents saw value in using objective measures to provide real-time feedback on adherence. However, approaches that involve unannounced home visits for sample collection or spot checks of ring use, which could provide significant value to adherence feedback efforts, were met with skepticism. Additional research on the acceptability of these methods to potential trial participants and trial staff is recommended.

Relationship between Human Immunodeficiency Virus (HIV) Knowledge, HIV-Related Stigma, and HIV Testing among Young Black Adults in a Southeastern City.

The southeast is identified as the epicenter of the nation's human immunodeficiency virus (HIV) epidemic, accounting for nearly 44% of all persons living with a HIV diagnosis in the United States. HIV stigma and knowledge have been cited as some of the complex factors increasing risk of acquiring HIV within African-American communities. We sought to understand how HIV knowledge and HIV-related stigma impact HIV testing experience among young Black adults who completed a community-based participatory research survey in a Southeastern city. Survey measures were developed with active engagement among the research team and community members, with the goal of balancing community knowledge, interests and concerns with scientific considerations, and the realities of funding and the project timeline. A total of 508 of the 513 audio computer-assisted self-interview questionnaires completed were analyzed. Eighty-one percent of participants had ever tested and had an intention-to-test for HIV in the next 12 months. Overall, analyses revealed low HIV-related stigma and relatively moderate to high HIV knowledge among young Black adults in the Southeastern city. Logistic regression indicated that having ever tested for HIV was positively correlated with HIV knowledge [odds ratio (OR): 1.50; 95% confidence interval (CI): 1.23-1.84, p < 0.001], but inversely correlated with low HIV-related stigma (OR: 0.08; 95% CI: 0.01-0.76, p < 0.03). However, there were no significant relationships between HIV-related stigma, HIV knowledge, and intention-to test for HIV in the future. These findings suggest that reducing HIV-related stigma and increasing HIV knowledge are not sufficient in promoting HIV testing (i.e., intention-to-test) among young Black adults in this city, unless specific emphasis is placed on addressing internalized HIV-related stigma and misperceptions about HIV prevention and control.

Social Context of Adherence in an Open-Label 1 % Tenofovir Gel Trial: Gender Dynamics and Disclosure in KwaZulu-Natal, South Africa.

CAPRISA 008, an open-label extension study of tenofovir gel with coitally-related dosing, provided an opportunity to explore the relationship between product adherence and gender dynamics in a context where women knew they were receiving an active product with evidence of HIV prevention effectiveness. Interviews with 63 CAPRISA 008 participants and 13 male partners in KwaZulu-Natal, South Africa, highlighted that the process of negotiating gel use was determined in part by relationship dynamics including the duration of the relationship, the living situation, an evaluation of the relationship (e.g., partner intimacy and relationship expectations) and culturally-defined steps for formalizing the relationship. While disclosure facilitated adherence for many, others reported using the gel effectively with no disclosure, and in some situations disclosure was a barrier to adherence. Women should be supported in their choice about what to disclose and have opportunity to use this and similar products without their partners' knowledge or acquiescence.

Concurrency and Other Sexual Risk Behaviors Among Black Young Adults in a Southeastern City.

Black Americans continue to have higher rates of HIV disease than other races/ethnicities. Conventional individual-level risk behaviors do not fully account for these racial/ethnic disparities. Sexual concurrency may help explain them. Respondent-driven sampling (RDS) was used to enroll 508 sexually active 18- to 30-year-old Black men and women in Durham, North Carolina in a cross-sectional survey on HIV-related topics. Consistent condom use was low for all participants, especially with steady partners. Concurrent partnerships in the past 6 months were relatively common for both men (38%) and women (25%). In general, men involved in concurrent relationships engaged in more risk behaviors than other men (e.g., inconsistent condom use and alcohol and drug use). A majority of concurrent partnerships involved steady partners. HIV-prevention programs should address the risks of concurrency and factors that discourage condom use, especially with steady partners with whom condom use is particularly low.

HIV Testing Experience and Risk Behavior Among Sexually Active Black Young Adults: A CBPR-Based Study Using Respondent-Driven Sampling in Durham, North Carolina.

African Americans are disproportionately affected by the HIV epidemic inclusive of men who have sex with men, heterosexual men, and women. As part of a community-based participatory research study we assessed HIV testing experience among sexually active 18-30 year old Black men and women in Durham, NC. Of 508 participants, 173 (74 %) men and 236 (86 %; p = 0.0008) women reported ever being tested. Barriers to testing (e.g., perceived risk and stigma) were the same for men and women, but men fell behind mainly because a primary facilitator of testing-routine screening in clinical settings-was more effective at reaching women. Structural and behavioral risk factors associated with HIV infection were prevalent but did not predict HIV testing experience. Reduced access to health care services for low income Black young adults may exacerbate HIV testing barriers that already exist for men and undermine previous success rates in reaching women.