Equitable inclusion of diverse populations in oncology clinical trials: deterrents and drivers.

The burden of cancer exerts a disproportionate impact across different regions and population subsets. Disease-specific attributes, coupled with genetic and socioeconomic factors, significantly influence cancer treatment outcomes. Precision oncology promises the development of safe and effective options for specific ethnic phenotypes and clinicodemographic profiles. Currently, clinical trials are concentrated in resource-rich geographies with younger, healthier, white, educated, and empowered populations. Vulnerable and marginalized people are often deprived of opportunities to participate in clinical trials. Despite consistent endeavors by regulators, industry, and other stakeholders, factors including diversity in trial regulations and patient and provider-related cultural, logistic, and operational barriers limit the inclusiveness of clinical trials. Understanding and addressing these constraints by collaborative actions involving regulatory initiatives, industry, patient advocacy groups, community engagement in a culturally sensitive manner, and designing and promoting decentralized clinical trials are vital to establishing a clinical research ecosystem that promotes equity in the representation of population subgroups.

Barriers to ART adherence & follow ups among patients attending ART centres in Maharashtra, India.

BACKGROUND & OBJECTIVES: Adherence to ART is a patient specific issue influenced by a variety of situations that a patient may encounter, especially in resource-limited settings. A study was conducted to understand factors and influencers of adherence to ART and their follow ups among patients attending ART centres in Maharashtra, India. METHODS: Between January and March 2009, barriers to ART adherence among 32 patients at three selected ART centres functioning under national ART roll-out programme in Maharashtra, India, were studied using qualitative methods. Consenting patients were interviewed to assess barriers to ART adherence. Constant comparison method was used to identify grounded codes. RESULTS: Patients reported multiple barriers to ART adherence and follow up as (i) Financial barriers where the contributing factors were unemployment, economic dependency, and debt, (ii) social norm of attending family rituals, and fulfilling social obligations emerged as socio-cultural barriers, (iii) patients' belief, attitude and behaviour towards medication and self-perceived stigma were the reasons for sub-optimal adherence, and (iv) long waiting period, doctor-patient relationship and less time devoted in counselling at the center contributed to missed visits. INTERPRETATION & CONCLUSIONS: Mainstreaming ART can facilitate access and address 'missed doses' due to travel and migration. A 'morning' and 'evening' ART centre/s hours may reduce work absenteeism and help in time management. Proactive 'adherence probing' and probing on internalized stigma might optimize adherence. Adherence probing to prevent transitioning to suboptimal adherence among patients stable on ART is recommended.

Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India.

Acceptability and adherence in clinical trials of microbicides may possibly predict their acceptance by the community. In this study, we investigated the acceptability and adherence of Praneem polyherbal tablet, a candidate microbicide, among 100 HIV-uninfected participants of a Phase II randomised, double-blind, placebo-controlled trial in Pune, India, conducted between June 2004 and February 2006 involving 6 months of coitally-dependent product use. The relationship between five acceptability domains and adherence to product use during the study period was explored. Acceptability and adherence were assessed among 95 study participants completing all study follow-ups. One hundred percent adherence (product use during each sex act for the study period) was reported by 67 participants (70.5%). The majority of participants reported acceptability towards all product characteristics. Product odour was reported to be a concern both in the placebo and Praneem arms. Participants from the Praneem arm [adjusted odds ratio (AOR)=3.8; 95% CI 1.4-10.8] and participants reporting lower acceptability for experience of product use during the sex act (AOR=4.2; 95% CI 1.0-17.3) were more likely to have partial adherence. In conclusion, the study product was acceptable to the majority of participants. However, barriers to adherence attributable to undesirable sexual experiences need to be addressed.

Acceptability of PRO2000 vaginal gel among HIV un-infected women in Pune, India.

Acceptability of PRO2000 Gel, a candidate vaginal microbicide, among participants of its Phase I safety study in Pune, India is reported here. Forty-two eligible women were enrolled in a study requiring twice daily intra-vaginal product use for 14 consecutive days between menses. Acceptability was assessed at study exit through structured questionnaires among 41 participants who completed the product use, and five focus group discussions involving 31 study participants. The participants generally liked the product (40/41, 97.2%), especially its colour (40, 97.2%) and consistency (35, 85.3%). Thirty-four participants reported sexual intercourse within one hour of product use, at least once during the study period and sexual pleasure was reported to be better or unaffected among (30, 88.2%) participants. Nearly 70% did not like its smell and mentioned preference for a product that would be unnoticeable to the male partner. Participating women were concerned about privacy in usage and storage of the product. Acceptability of PRO2000 vaginal gel was good, but its smell will have to be improved. Counselling to address women's concerns about privacy and storage will be crucial. Women's preference for unnoticeable product indicates their empowerment and willingness to accept female-controlled options for HIV prevention.

A group-based intervention to increase condom use among HIV serodiscordant couples in India, Thailand, and Uganda.

This study assessed the feasibility of a group-based couples intervention to increase condom use in HIV serodiscordant couples in three countries (India, Thailand and Uganda). The intervention focused on communication, problem solving, and negotiation skills. Forty-three couples enrolled in the intervention (15 in India, 14 in Thailand, and 14 in Uganda) and 40 couples completed all study activities. Participants were interviewed at baseline and at one and three months post- intervention. The intervention consisted of two same sex sessions and two couples sessions with 'homework' to practice skills between sessions. The same intervention modules were used at each site, tailored for local appropriateness. Participants at each site were enthusiastic about the intervention, citing information about HIV serodiscordancy and the opportunity to meet couples 'like us' as important features. Participants reported increased comfort discussing sex and condoms with their partner, although some participants remain concerned about situations when condoms might not be used (e.g. when drunk). At three-month follow up 90% of the participants reported having been able to use the skills from the intervention with their partner. Our results highlight the feasibility of this couples group-based intervention and the need for ongoing support for discordant couples.

Acceptability of Praneem polyherbal vaginal tablet among HIV uninfected women & their male partners in Pune, India--Phase I study.

BACKGROUND & OBJECTIVE: The number of HIV infected women is steadily increasing worldwide and women controlled methods to prevent HIV are urgently needed. Vaginal microbicides are products for vaginal administration that can be used to prevent HIV infection and other sexually transmitted diseases (STDs). We conducted a Phase I safety and acceptability study of Praneem polyherbal tablet, a candidate microbicide, among HIV uninfected women in Pune, India. METHODS: Twenty eligible women were requested to use the product intravaginally once daily for 14 consecutive days between menses. Safety was assessed by clinical examination, laboratory monitoring and colposcopy. Acceptability was assessed after 14 days of product use through structured questionnaires, focus group discussions among participating women, and in-depth interviews with a subset of 5 randomly selected male partners. RESULTS: Praneem polyherbal tablet was found acceptable by the study participants with 90 per cent of the participants showing 80 per cent and more acceptability score. Discharge of the product residue was reported as a concern by 6 (30%) of participants. Nineteen (95%) female participants liked the smell and the same number reported that the product was easy to use and did not affect the usual sexual pleasure. However, men reported lack of sexual satisfaction. INTERPRETATION & CONCLUSION: Product characteristics received good acceptability score in women. However, studies of long-term safety and acceptability among at-risk population would provide more detailed information about its long term acceptability.

Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India.

BACKGROUND & OBJECTIVES: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HIV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). METHODS: Twenty three HIV seronegative women enrolled in the study were given Today pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. RESULTS: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. INTERPRETATION & CONCLUSION: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

The reliability and validity of the Modified Condom Outcome Expectancy Scale (MCOES) among an international sample of HIV-negative partners of people living with HIV/AIDS.

Safer sexual behaviour is vital in curbing the HlV epidemic in many developing countries where the epidemic is primarily transmitted through heterosexual sex. Reliable and valid assessment of factors related to HIV risk behaviours are important in testing behavioural theories as well as informing effective AIDS prevention programmes. The current study tests the reliability and validity of a modified version of the Condom Outcome Expectancy Scale (COES) among a sample of HI'-negative sexual partners (n = 100) of HIV-infected individuals in Pune, India, Chang Mai,Thailand and Kampala, Uganda. Internal consistency reliability was measured using Cronbach's alpha coefficient, which had a value of 0.80 for the entire sample, with site-specific values of. 0.78 for India; 0.75 for Thailand; and 0.79 for Uganda. Test-retest reliability was conducted to test the scale's stability over time with 60% of the sample, resulting in a Cronbach's alpha coefficient of 0.70. The scale's structure was explored by analyzing response scores on the items using principal components analysis, which yielded a two-factor solution. The study indicates the utility of a modified version of the widely tested COES across international settings. Such research is necessary in understanding intervention targets across international settings.

Patient-led partner referral in a district hospital based STD clinic.

CONTEXT: Sexual communication and appropriate treatment of sexual partners is critical to the success of STD and HIV/AIDS prevention and control. AIMS: To understand factors influencing intention of STD patients to inform their regular sexual partners and identify predictors influencing actual return of the partners. SETTINGS AND DESIGN: A non-randomised survey of patients attending STD clinic in a district hospital between May and November 2000. METHODS AND MATERIAL: 182 patients were administered structured questionnaires to understand their intention to notify their regular sexual partners and encouraged to refer their regular sexual partners to the clinic for management. Factors related to intent to notify partners and actual partner referral were analysed. STATISTICAL ANALYSIS USED: Chi square test and forward stepwise logistic regression. RESULTS: Of the 182 STD patients 77.47% expressed their positive intention to notify their regular sexual partners. However, overall partner return rate was 40.65%. Patients from a better economic class (p=0.014), those who had sex since having the disease (p=0.001), those who felt it was easy to tell their partners (p=0.047) and perceived the necessity of investigating their partners (p<0.001) were more likely to have an intention to notify their partners. Independent predictors of actual return of sexual partners were patients' perception of partners' susceptibility (p=0.044), positive intention to notify partners (p=0.001), partners already informed before clinic visit (p=0.030) and presence of genital ulcerative diseases (p=0.033). CONCLUSIONS: STD clinic counselling and education should focus on risk reduction, partner susceptibility, role of STDs in HIV transmission and improving spousal communication.