User-Centered Design: Developing the RELI Delivery System - a Low-Cost, Non-Electric, Pneumatic Infusion Pump.

PURPOSE: Infusion pumps are the preferred method for intravenous delivery of drugs and fluids, and an essential tool in health facilities. Their high cost, complexity and reliance on electricity pose serious challenges to wide-spread use, availability and access in low- and middle-income countries. PATH developed the RELI Delivery System (RELI), a low cost, non-electric infusion pump to address these challenges. Input collected from fifty-nine newborn and maternal care providers and from seven national level decision makers in Uganda was used to guide product development, further informing product design requirements, and optimal design features to best serve their needs. METHODS: A formative evaluation following a mixed methods approach including focus group discussions (FGDs), stakeholder interviews, and observations was used to collect data from end users. RESULTS: Stakeholders provided critical input on the RELI prototype design features, safety criteria, and contexts of use of infusion pumps, as well as recommendations for design refinements. Infusion systems are greatly needed but not readily available and their use is limited to well-resourced higher level facilities, even though the need is high in non-tertiary care hospital where patient volume is high, resources are scarce, power is inconsistent, and facilities are understaffed and overcrowded. Users expressed a need for an affordable and simple device with an intuitive user interface, clear instructions for use, and basic safety features. CONCLUSION: The study provided important guidance for further design refinements based on input from respondents and confirmed the need for robust, affordable, infusion pumps that meet the requirements for use in low-resource settings.

Facility- and community-based delivery of micronutrient powders in Uganda: Opening the black box of implementation using mixed methods.

Micronutrient powders (MNP) have the potential to increase micronutrient intake, yet documentation of implementation lessons remains a gap. This paper presents results of a pilot in Uganda comparing community- and facility-based delivery of MNP and documenting experiences of caregivers and distributors. The pilot's mixed method evaluation included a cross-sectional endline survey, monthly household visits, and midline and endline interviews. Primary outcomes were ever-covered (received ≥1 MNP packet), repeat-coverage (received ≥2 MNP packets), and adherence (consumed no more than 1 MNP sachet per day, consumed MNP with food, and consumed MNP 3+ days in past week). An adjusted Wald chi-square test compared differences in programme outcomes between arms, and logit regression identified predictors to adherence. Key informant interviews were coded thematically. Most programme outcomes in the endline survey were statistically significantly higher in the community arm, although in both arms, adherence was lower than other outcomes (adherence 31.4% in facility vs. 58.3% in community arm). Counselling, receipt of communication materials, perceived positive effects, MNP knowledge, and child liking MNP were consistent predictors of adherence in both arms. Qualitative findings corroborated survey results, revealing that social encouragement and advocacy facilitated use and that forgetting to give MNP was a barrier. Facility arm caregivers also cited distance, time, and transportation cost as barriers. Distributors had positive experiences with training and supervision but experienced increased workloads in both arms. MNP programme design is context-specific but could benefit from strengthened community sensitization, continued and more effective counselling for caregivers, and increased support for distributors.

Men at risk; a qualitative study on HIV risk, gender identity and violence among men who have sex with men who report high risk behavior in Kampala, Uganda.

In Uganda, men who have sex with men (MSM) are at high risk for HIV. Between May 2008 and February 2009 in Kampala, Uganda, we used respondent driven sampling (RDS) to recruit 295 MSM≥18 years who reported having had sex with another man in the preceding three months. The parent study conducted HIV and STI testing and collected demographic and HIV-related behavioral data through audio computer-assisted self-administered interviews. We conducted a nested qualitative sub-study with 16 men purposively sampled from among the survey participants based on responses to behavioral variables indicating higher risk for HIV infection. Sub-study participants were interviewed face-to-face. Domains of inquiry included sexual orientation, gender identity, condom use, stigma, discrimination, violence and health seeking behavior. Emergent themes included a description of sexual orientation/gender identity categories. All groups of men described conflicting feelings related to their sexual orientation and contextual issues that do not accept same-sex identities or behaviors and non-normative gender presentation. The emerging domains for facilitating condom use included: lack of trust in partner and fear of HIV infection. We discuss themes in the context of social and policy issues surrounding homosexuality and HIV prevention in Uganda that directly affect men's lives, risk and health-promoting behaviors.

'Pregnancy comes accidentally--like it did with me': reproductive decisions among women on ART and their partners in rural Uganda.

BACKGROUND: As highly active antiretroviral therapy (ART) restores health, fertility and sexual activity among HIV-infected adults, understanding how ART influences reproductive desires and decisions could inform interventions to reduce sexual and vertical HIV transmission risk. METHODS: We performed a qualitative sub-study among a Ugandan cohort of 1,000 adults on ART with four purposively selected categories of participants: pregnant, not pregnant, delivered, and aborted. In-depth interviews examined relationships between HIV, ART and pregnancy, desire for children, perceived risks and benefits of pregnancy, decision-making regarding reproduction and family planning (FP) among 29 women and 16 male partners. Analysis focused on dominant explanations for emerging themes across and within participant groups. RESULTS: Among those who had conceived, most couples stated that their pregnancy was unintentional, and often occurred because they believed that they were infertile due to HIV. Perceived reasons for women not getting pregnant included: ill health (included HIV infection and ART), having enough children, financial constraints, fear of mother-to-child HIV transmission or transmission to partner, death of a child, and health education. Most women reported FP experiences with condoms and hormonal injections only. Men had limited FP information apart from condoms. CONCLUSIONS: Counselling at ART initiation may not be sufficient to enable women who do not desire children to adopt relevant family planning practices. On-going reproductive health education and FP services, with emphasis on the restoration of fertility after ART initiation, should be integrated into ART programs for men and women.

Partners at risk: motivations, strategies, and challenges to HIV transmission risk reduction among HIV-infected men and women in Uganda.

Prevention with positives (PWP) is a fundamental component of HIV prevention in industrialized countries. Despite the estimated 22.4 million HIV-infected adults in Africa (UNAIDS, 2006), culturally appropriate PWP guidelines have not been developed for this region. In order to inform these guidelines, we conducted 37 interviews (17 women, 20 men, no couples) from October 2003 to May 2004 with purposefully selected HIV-infected individuals in care in Uganda. Participants reported increased condom use and reduced intercourse frequency and numbers of partners after testing HIV-positive. Motivations for behavior change included concerns for personal health and the health of others, and decreased libido. Gender-power inequities (sometimes manifesting in forced sex), pain experienced by women while using condoms, decreased pleasure for men while using condoms, lack of social support, and desire for children appear to have resulted in increased risk for uninfected partners. Interventions addressing domestic violence, partner negotiation, use of lubricants and alternative sexual activities could increase condom use and/or decrease sexual activity and/or numbers of partners, thereby reducing HIV transmission risk.

The virus stops with me: HIV-infected Ugandans' motivations in preventing HIV transmission.

Few Positive Prevention interventions have been implemented in Africa; however, greater attention is now being paid to interventions that include messages of personal responsibility or altruism that may motivate HIV-infected individuals towards HIV prevention behaviors in Africa. We conducted 47 in-depth interviews in 2004 with HIV-infected men and women purposefully sampled to represent a range of sexual activities among clients of an AIDS support organization in Uganda. Qualitative interviews were selected from a cross-sectional survey of 1092 HIV-infected men and women. Clients were interviewed about their concerns around sexual HIV transmission, feelings of responsibility and reasons for these feelings, as well as about the challenges and consequences of actions to prevent HIV transmission. The reasons they provided for their sense of prevention responsibility revolved around ethical and practical themes. Responsibility toward sexual partners was linked to the belief that conscious transmission of HIV equals murder, would cause physical and emotional harm, and would leave children orphaned. The primary reason specific to preventing HIV transmission to unborn children was the perception that they are 'innocent'. Most participants felt that HIV-infected individuals held a greater responsibility for preventing HIV transmission than did HIV-uninfected individuals. Respondents reported that their sense of responsibility lead them to reduce HIV transmission risk, encourage partner testing, disclose HIV test results, and assume an HIV/AIDS educator role. Challenges to HIV preventive behavior and altruistic intentions included: sexual desire; inconsistent condom use, especially in long term relationships; myths around condom use; fear of disclosure; gender-power dynamics; and social and financial pressure. Our finding that altruism played an important role in motivating preventive behaviors among HIV-infected persons in Uganda supports the inclusion of altruistic prevention and counseling messages within Positive Prevention interventions.

Processes and outcomes of HIV serostatus disclosure to sexual partners among people living with HIV in Uganda.

Disclosure of HIV serostatus to sexual partners supports risk reduction and facilitates access to prevention and care services for people living with HIV/AIDS. To assess health and social predictors of disclosure as well as to explore and describe the process, experiences and outcomes related to disclosure of HIV-infected men and women in Eastern Uganda, we conducted a study among HIV-infected men and women who were clients of The AIDS Support Organization (TASO) in Jinja, Uganda. We enrolled TASO clients in a cross-sectional study on transmission risk behavior. Demographic and behavioral data and CD4 cell count measurements were collected. Among 1,092 participants, 42% were currently sexually active and 69% had disclosed their HIV serostatus to their most recent sexual partner. Multivariate logistic regression analysis showed that disclosure of HIV-status was associated with being married, having attended TASO for more than 2 years, increased condom use, and knowledge of partner's serostatus. From these clients, 45 men and women were purposefully selected and interviewed in-depth on disclosure issues. Positive outcomes included risk reduction behavior, partner testing, increased care-seeking behavior, anxiety relief, increased sexual communication, and motivation to plan for the future.

Long-term experience providing antiretroviral drugs in a fee-for-service HIV clinic in Uganda: evidence of extended virologic and CD4+ cell count responses.

OBJECTIVE: To describe the long-term experience of providing anti-retroviral (ARV) therapy, including CD4 cell count and virologic response, at St. Francis Hospital, Nsambya, Uganda. METHODS: The HIV clinic established in 1998 is a fee-for-service model where patients pay for ARVs. The care of patients who started ARVs from August 1, 1998 until October 31, 2000 was evaluated through December 31, 2002. Data were collected at the HIV clinic on standardized clinical forms. These patients had free CD4 cell count and viral load testing performed at times determined by the physician. All persons who had >/=1 CD4 cell count or viral load done >/=90 days after starting therapy were evaluated. RESULTS: Three hundred twenty-one patients (49% women, 66% ARV naive, median age = 38 years, median CD4 cell count = 79 cells/mm, and median viral load = 249,489 copies/mL) attended the HIV clinic. Two hundred sixty-three (82%) patients returned at least once after the initial visit, of whom 54 (21%) had an interruption in therapy for >1 year. One hundred thirty-five patients were in care in 2002, 69 were known to have died (9 of whom died in 2002), and 68 were lost to follow-up. The probability of remaining alive and in care at 1 year was 0.56 (95% confidence interval [CI]: 0.50-0.61), 0.46 (95% CI: 0.41-0.51) at 2 years, 0.40 (95% CI: 0.34-0.45) at 3 years, and 0.35 (95% CI: 0.29-0.41) at 4 years. In an on-treatment analysis, the median CD4 cell count increase during year 1 was +55 cells/mm, +112 cells/mm during year 2, +142 cells/mm during year 3, and +131 cells/mm during year 4. The median log viral load change from baseline during year 1 was -1.4 copies/mL, -1.32 copies/mL during year 2, -1.9 copies/mL during year 3, and -1.51 copies/mL during year 4. CONCLUSIONS: This fee-for-service HIV clinic providing ARV treatment has successfully operated and managed patients for more than 4 years. Those who survived and remained on therapy derived long-term virologic and immunologic responses to ARV drugs in a manner similar to that observed in industrialized countries. Strategies to reduce the financial burden and other barriers to uninterrupted care as well as incentives to increase such practice models should be further explored in the African context.