Evaluation of the effects of Artemisia Annua L. and Moringa Oleifera Lam. on CD4 count and viral load among PLWH on ART at Mbarara Regional Referral Hospital: a double-blind randomized controlled clinical trial.

BACKGROUND: Initiation of ART among people living with HIV (PLWH) having a CD4 count ≤ 350cells/µl, produces poor immunological recovery, putting them at a high risk of opportunistic infections. To mitigate this, PLWH on ART in Uganda frequently use herbal remedies like Artemisia annua and Moringa oleifera, but their clinical benefits and potential antiretroviral (ARV) interactions remain unknown. This study examined the impact of A. annua and M. oleifera on CD4 count, viral load, and potential ARV interactions among PLWH on ART at an HIV clinic in Uganda. METHODS: 282 HIV-positive participants on antiretroviral therapy (ART) with a CD4 count ≤ 350cells/µl were randomized in a double-blind clinical trial to receive daily, in addition to their routine standard of care either; 1) A. annua leaf powder, 2) A. annua plus M. oleifera, and 3) routine standard of care only. Change in the CD4 count at 12 months was our primary outcome. Secondary outcomes included changes in viral load, complete blood count, and ARV plasma levels. Participants were followed up for a year and outcomes were measured at baseline, 6 and 12 months. RESULTS: At 12 months of patient follow-up, in addition to standard of care, administration of A. annua + M. oleifera resulted in an absolute mean CD4 increment of 105.06 cells/µl, (p < 0.001), while administration of A. annua plus routine standard of care registered an absolute mean CD4 increment of 60.84 cells/µl, (p = 0.001) compared to the control group. The A. annua plus M. oleifera treatment significantly reduced viral load (p = 0.022) and increased platelet count (p = 0.025) and white blood cell counts (p = 0.003) compared to standard care alone, with no significant difference in ARV plasma levels across the groups. CONCLUSION: A combination of A. annua and M. oleifera leaf powders taken once a day together with the routine standard of care produced a significant increase in CD4 count, WBCs, platelets, and viral load suppression among individuals on ART. A. annua and M. oleifera have potential to offer an affordable alternative remedy for managing HIV infection, particularly in low-resource communities lacking ART access. TRIAL REGISTRATION: ClinicalTrials.gov NCT03366922.

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.

BACKGROUND: In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. METHODS AND FINDINGS: We enrolled HIV-negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure ("high" adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as "high." Women who became pregnant were initially exited from the cohort by design; from March 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group. CONCLUSIONS: Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1.

'I still desire to have a child': a qualitative analysis of intersectional HIV- and childlessness-related stigma in rural southwestern Uganda.

This study explored the intersecting forms of stigma experienced by HIV-serodifferent couples with unmet reproductive goals in rural Uganda. The parent mixed-methods study, which included 131 HIV-exposed women with plans for pregnancy, offered comprehensive HIV prevention counselling and care over a nine-month period. In-depth interviews were conducted with 37 women and seven male partners to explore care experiences and the use of safer conception strategies. This secondary analysis explored how challenges conceiving informed pregnancy plans and HIV prevention behaviours. The following themes were developed (1) partnership conflicts arise from HIV- and infertility-related forms of stigma, contributing to gender-based violence, partnership dissolution and the pursuit of new partners; (2) cultural and gender norms pressure men and women to conceive and maintain partnerships, which is complicated by the stigma directed towards serodifferent couples; (3) frustration with low partner participation in safer conception strategies led to the decreased use of these methods of HIV prevention; (4) health care provider support promotes continued hope of conception and helps overcome stigma. In HIV-affected partnerships, these intersecting forms of stigma may impact HIV prevention. Seeking to fulfil their reproductive needs, partners may increase HIV transmission opportunities as they engage in condomless sex with additional partners and decrease adherence to prevention strategies. Future research programmes should consider the integration of fertility counselling with reproductive and sexual health care.

Understanding the Effect of a Healthcare Provider-Led Family Planning Support Intervention on Contraception use and Pregnancy Desires among Postpartum Women Living with HIV in Southwestern Uganda.

Modern contraceptive prevalence among women living with HIV (WLWH) in Uganda is still low at 45%, and up to a third of women are likely to discontinue the method within the first year of initiation. This increases risks of unplanned pregnancies, perinatal HIV transmission and pregnancy complications. We aim to explore and explain the mechanism of effect of a family planning support intervention investigated in a randomized controlled trial conducted between October 2016 and June 2018 among 320 postpartum WLWH at a referral hospital in Southwestern Uganda that led to improved uptake, decreased contraception discontinuation and lowered pregnancy rates. Thirty WLWH and 10 of their primary sexual partners who participated in this trial were purposively selected and interviewed in the local language; interviews were digitally recorded. Translated transcripts were generated and coded. Coded data were iteratively reviewed and sorted to derive descriptive categories using an inductive content analytic approach. Up to 83% of women wanted to avoid pregnancy within the first year postpartum. Qualitative data showed that contraception uptake and use were influenced by: 1) Participant awareness and understanding of different methods available; 2) Participant perception of offered health services; 3) Healthcare provider (HCP) socio-cultural sensitivity to individual experiences and (mis)conceptions surrounding contraception; 4) Having tactile engagement, follow-up reminders and a reference to prompt action or discussions with partners. Supportive and culturally sensitive HCPs and systems facilitated information sharing leading to increased patient awareness and understanding of the contraceptive methods, and improved health user experience, care engagement, confidence and willingness to take up and continue using modern contraceptive methods.

Sexual and Relationship Benefits of a Safer Conception Intervention Among Men with HIV Who Seek to Have Children with Serodifferent Partners in Uganda.

Many men with HIV (MWH) in Uganda desire children, yet seldom receive reproductive counseling related to HIV care. Because men are under engaged in safer conception programming, they miss opportunities to reap the benefits of these programs. The objective of this sub-analysis was to explore the relationship and intimacy benefits of integrating safer conception counseling and strategies into HIV care, an emergent theme from exit interviews with men who participated in a pilot safer conception program and their partners. Twenty interviews were conducted with MWH who desired a child in the next year with an HIV-uninfected/status unknown female partner, and separate interviews were conducted with female partners (n = 20); of the 40 interviews, 28 were completed by both members of a couple. Interviews explored experiences participating in The Healthy Families program, which offered MWH safer conception counseling and access to specific strategies. Data were analyzed using thematic analysis. Three major subthemes or "pathways" to the relationship and intimacy benefits associated with participation in the program emerged: (1) improved dyadic communication; (2) joint decision-making and power equity in the context of reproduction; and (3) increased sexual and relational intimacy, driven by reduced fear of HIV transmission and relationship dissolution. These data suggest that the intervention not only helped couples realize their reproductive goals; it also improved relationship dynamics and facilitated intimacy, strengthening partnerships and reducing fears of separation. Directly addressing these benefits with MWH and their partners may increase engagement with HIV prevention strategies for conception.

Barriers and facilitators of male engagement in Community Client-Led Antiretroviral therapy Delivery groups (CCLADS) for HIV care and treatment in Southwestern Uganda: a qualitative study.

BACKGROUND: Male engagement in HIV programs is a persistent challenge that results in poor utilization of HIV care services. Differentiated service delivery models, such as Community Client-Led Antiretroviral Delivery Groups (CCLADs), provide an opportunity for male engagement in HIV care. In southwestern Uganda. In southwestern Uganda few men living with HIV (MLWHIV) are involved in CCLADS. We aimed to identify facilitators, barriers and perceptions to CCLADs enrollment by MLWHIV at ART Clinics in southwestern Uganda. METHODS: A qualitative study was conducted among MLWHIV who were registered and receiving ART at two ART Clinics/health facilities in southwestern Uganda, irrespective of their enrollment status into CCLADs. In-depth interviews (IDI) were conducted among recruited HIV positive men, and Key informant interviews (KIIs) among clinic in-charges and counselors, women enrolled in CCLADS using a semi-structured interview guide. We used thematic analysis to analyze the data from the interviews. RESULTS: We conducted 16 interviews, 7 KII and 8 IDI were conducted. MLWHIV and key informants shared the facilitators and barriers. Men who were not involved in CCLADs shared the barriers to joining the CCLADs. The themes identified included 1. Motivations to join CCLADS 2. Challenges related to CCLADS initiation 3. Perceived facilitators for male participation in CCLADS, 4. Perceived barriers for male participation in CCLADS and 5. Proposed strategies for best implementation of CCLADs for better male engagement. Overall men liked the idea of CCLADs but they had preferences on how they should be implemented. CONCLUSION: Men's enrollment into CCLADs is still low despite the benefits. Addressing the barriers to men's engagement and adopting proposed strategies may improve men's enrollment in CCLADS and thus improve their access to ART, Adherence and quality of life.

Electronic Adherence Monitoring May Facilitate Intentional HIV Status Disclosure Among People Living with HIV in Rural Southwestern Uganda.

HIV status disclosure remains one of the major challenges to effective HIV prevention. Given the complexities and low rates of disclosure, new innovative strategies are needed. Since electronic adherence monitoring (EAM) are unique mobile devices that light up when transmitting data, those who see them often want to know more about them, which can potentially result in HIV status disclosure. We conducted a qualitative study to explore patient experiences with EAM for antiretroviral therapy (ART) in Uganda with a goal of understanding potential ethical concerns, including disclosure. Unexpectedly, several participants reported intentionally using EAM to facilitate HIV status disclosure to others in order to get social support, encourage HIV testing, and create awareness about HIV. Although researchers and clinicians need to be mindful of the potential for unintended HIV status disclosure through the use of EAM, they should also recognize the potential of this approach to support intended disclosure.

Provision of family planning vouchers and early initiation of postpartum contraceptive use among women living with HIV in southwestern Uganda: A randomized controlled trial.

BACKGROUND: Unwanted pregnancies remain a burden for women living with HIV (WLWH). Family planning prevents unplanned pregnancies while promoting longer birth intervals, key strategies to eliminate perinatal transmission of HIV and promote maternal and child health. We evaluated the effect of a family planning voucher, inclusive of immediate postpartum counseling, on uptake, early initiation, and continuation of modern contraceptive methods among recently postpartum WLWH delivering at a publicly funded regional referral hospital in rural, southwestern Uganda. METHODS AND FINDINGS: We performed a randomized controlled trial between October, 2016 and June, 2018 at a referral hospital in southwestern Uganda. This interim analysis includes adult WLWH randomized and enrolled equally to receive a family planning voucher or standard of care (control). Enrolled postpartum WLWH completed an interviewer-administered questionnaire at enrollment and 6 months postpartum. Our primary outcome of interest for this analysis is initiation of a modern family planning method within 8 weeks postpartum. Secondary outcomes included family planning initiation at 12, 14, 16, and 20 weeks postpartum, family planning discontinuation and/or change, pregnancy incidence, and mean time without contraception. The trial was registered with clinicaltrials.gov (NCT02964169). At enrollment, half of the women in both the voucher (N = 87, 55%) and control (N = 86, 54%) groups wanted to have a child in 2 years postpartum. Over 80% of referent pregnancies in the voucher (N = 136, 86%) and control (N = 128, 81%) groups were planned. All women were accessing ART. The mean CD4 count was 396 cells/mm3 (SD = 61) for those enrolled in the control group versus 393 cells/mm3 (SD = 64) in the family planning voucher group. By 8 weeks postpartum, family planning was initiated in 144 (91%) participants in the voucher group and 83 (52%) participants in the control group (odds ratio [OR] 9.42; CI 4.67-13.97, P < 0.001). We also found high family planning uptake rates for both groups, with higher rates among the intervention group at 12 weeks (OR 5.66; CI 2.65-12.12, P < 0.001), 14 weeks (OR 2.51; CI 1.31-4.79, P < 0.001), 16 weeks (OR 4.02; CI 1.66-9.77, P = 0.001), and 20 weeks (OR 3.65; CI 1.40-9.47, P = 0.004) postpartum. The average time to family planning initiation was reduced to 5.9 weeks (SD = 2.4) for those in the voucher group compared to 9.3 weeks (SD = 5) in the control (P < 0.001). One pregnancy was recorded in the group receiving standard of care; none were reported in the voucher group. Method mix did not differ by group: injectables were selected by most women (N = 150, 50%), and 52% of this proportion were in the experimental arm, with <10% in each arm selecting condoms, oral contraception, or intrauterine devices (IUDs). Similar proportions of women changed contraceptive methods over the 6-month follow-up in the voucher and control groups (N = 8, 5% versus N = 5, 4%; P = 0.467). More women in the control group discontinued contraception for 1 to 2 weeks (N = 19, 13% versus N = 7, 5%; P = 0.008) or more than 4 weeks (N = 15, 10% versus N = 3, 2%; P = 0.002) compared to those given a family planning voucher. The main limitation of this study is that its findings may not be generalized to settings without improved availability of contraceptives in publicly funded facilities. CONCLUSION: These findings indicate that a well-structured, time-bound family planning voucher program appeared to increase early postpartum contraceptive uptake and continuation in a setting in which users are faced with financial, knowledge, and structural barriers to contraceptive services. Further work should clarify the role of vouchers in empowering WLWH to avoid unintended pregnancies over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT02964169.

Factors Associated with Pregnancy Intentions Amongst Postpartum Women Living with HIV in Rural Southwestern Uganda.

Comprehensive HIV treatment and care makes it safer for women living with HIV (WLWH) to have the children they desire, partly through provision and appropriate use of effective contraception. However, nearly one third of WLWH in-care in a large Ugandan cohort became pregnant within 3 years of initiating ART and half of these incident pregnancies (45%) were unplanned. We therefore describe future pregnancy plans and associated factors among postpartum WLWH in rural southwestern Uganda in order to inform interventions promoting postpartum contraceptive uptake. This analysis includes baseline data collected from adult WLWH enrolled into a randomized controlled trial to evaluate the effect of family planning support versus standard of care at 12 months postpartum in southwestern Uganda. Enrolled postpartum WLWH completed an interviewer-administered questionnaire at enrolment. Among 320 enrolled women, mean age, CD4 count, and duration on ART was 28.9 (standard deviation [SD] 5.8) years, 395 cells/mm3 (SD = 62) and 4.6 years (SD = 3.9), respectively. One-hundred and eighty nine (59%) of women reported either personal (175, 55%) or partner (186, 58%) desire for more children in the next 2 years. Intentions to have more children was strongly associated with partner's desire for more children (AOR = 31.36; P < 0.000), referent pregnancy planned (AOR = 2.69; P = 0.050) and higher household income > 150,000 Shs per month (AOR = 1.37; P = 0.010). Previous use of modern contraception (AOR = 0.07; P = 0.001), increasing age (AOR = 0.34; P = 0.012), having > 2 own children living in a household (AOR = 0.42; P = 0.021) and parity > 2 (AOR = 0.59; P = 0.015) were associated with reduced odds of pregnancy intention. Our findings highlight the role male partners play in influencing pregnancy intentions postpartum and the importance of engaging men in sexual and reproductive health counselling about child spacing for the health of women, children, and families. This should be addressed alongside key individual-level social, demographic, economic and structural factors within which couples can understand risks of unplanned pregnancies and access effective contraceptive methods when they need or want them.

Resilience after withdrawing a technology-based medication adherence support intervention from people living with HIV in rural Uganda.

Technology-based interventions for behavior change, such as adherence monitors and SMS text messages, can improve adherence to HIV antiretroviral therapy. It is unclear, however, how the effects of such interventions are maintained when interventions are withdrawn. We explored resiliency of people living with HIV in coping with adherence to antiretroviral therapy (ART) after withdrawing an adherence support intervention of real-time adherence monitors linked to SMS text messages at study closure. This is a qualitative study conducted with former participants of a pilot randomized controlled trial after study closure. Between April 2016 and November 2016, we used convenient sampling to interview 28 of the 62 participants from the pilot trial, which was conducted in rural Uganda. Interviews elicited information on experiences of taking ART in the absence of the intervention, coping strategies, and changes in social support interactions. Data were analyzed inductively using content analysis. Most participants demonstrated resilience through learning adherence from the intervention; and internalizing the habit of medication adherence. They seemed to have a sense of self-esteem, positive thinking, and access to supportive relationships. Other participants employed adaptive coping strategies, such as using alternative cues (e.g., alarms), accessing spiritual support, and adjusting their medication time to their routine. A few participants lacked resiliency, lost the habit and struggled with adherence. They were dependent on the intervention, appeared isolated and psychologically stressed, and were unable to overcome challenges associated with poor social support systems. Intervention-related benefits may or may not persist after the intervention is withdrawn. Contingent on individuals" underlying characteristics and relationships, participants manifested resiliency through learning and internalization, as well as using alternative coping strategies. Such resiliency could facilitate the use of short-term interventions, which are particularly important for resource-limited settings. Participants should be referred to available additional support at study closure when needed.

Understanding Patterns of Social Support and Their Relationship to an ART Adherence Intervention Among Adults in Rural Southwestern Uganda.

SMS is a widely used technology globally and may also improve ART adherence, yet SMS notifications to social supporters following real-time detection of missed doses showed no clear benefit in a recent pilot trial. We examine the demographic and social-cultural dynamics that may explain this finding. In the trial, 63 HIV-positive individuals initiating ART received a real-time adherence monitor and were randomized to two types of SMS reminder interventions versus a control (no SMS). SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses. Like participants, social supporters were interviewed at enrollment, following their matched participant's adherence lapse and at exit. Social supporters with regular income (RR = 0.27, P = 0.001) were significantly associated with fewer adherence lapses. Instrumental support was associated with fewer adherence lapses only among social supporters who were food secure (RR = 0.58, P = 0.003). Qualitative interview data revealed diverse and complex economic and relationship dynamics, affecting social support. Resource availability in emotionally positive relationships seemingly facilitated helpful support, while limited resources prevented active provision of support for many. Effective social support appeared subject to social supporters' food security, economic stability and a well-functioning social network dependent on trust and supportive disclosure.

Functionality and acceptability of a wireless fetal heart rate monitoring device in term pregnant women in rural Southwestern Uganda.

BACKGROUND: Over 3 million stillbirths occur annually in sub Saharan Africa; most occur intrapartum and are largely preventable. The standard of care for fetal heart rate (FHR) assessment in most sub-Saharan African settings is a Pinard Stethoscope, limiting observation to one person, at one point in time. We aimed to test the functionality and acceptability of a wireless FHR monitor that could allow for expanded monitoring capacity in rural Southwestern Uganda. METHODS: In a mixed method prospective study, we enrolled 1) non-laboring healthy term pregnant women to wear the device for 30 min and 2) non-study clinicians to observe its use. The battery-powered prototype uses Doppler technology to measure fetal cardiotocographs (CTG), which are displayed via an android device and wirelessly transmit to cloud storage where they are accessible via a password protected website. Prototype functionality was assessed by the ability to obtain and transmit a 30-min CTG. Three obstetricians independently rated CTGs for readability and agreement between raters was calculated. All participants completed interviews on acceptability. RESULTS: Fifty pregnant women and 7 clinicians were enrolled. 46 (92.0%) CTGs were successfully recorded and stored. Mean scores for readability were 4.71, 4.71 and 4.83 (out of 5) with high agreement (intra class correlation 0.84; 95% CI 0.74 to 0.91). All pregnant women reported liking or really liking the device, as well as high levels of comfort, flexibility and usefulness of the prototype; all would recommend it to others. Clinicians described the prototype as portable, flexible, easy-to-use and a time saver. Adequate education for clinicians and women also seemed to improve correct usage and minimise concerns on safety of the device. CONCLUSIONS: This prototype wireless FHR monitor functioned well in a low-resource setting and was found to be acceptable and useful to both pregnant women and clinicians. The device also seemed to have potential to improve the experience of the users compared with standard of care and expand monitoring capacity in settings where bulky, wired or traditional equipment are unreliable. Further research needs to investigate the potential impact and cost of such innovations to improve perinatal outcomes.

Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial.

BACKGROUND: Postpartum hemorrhage (PPH) is a leading cause of maternal death in sub-Saharan Africa. Although the World Health Organization recommends use of oxytocin for prevention of PPH, misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration. There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol, particularly at the recommended dose of 600 µg, for prevention of PPH during active management of labor. METHODS AND FINDINGS: We performed a double-blind, double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda. We randomized 1,140 women to receive 600 µg of misoprostol sublingually or 10 IU of oxytocin intramuscularly, along with matching placebos for the treatment they did not receive. Our primary outcome of interest was PPH, defined as measured blood loss ≥ 500 ml within 24 h of delivery. Secondary outcomes included measured blood loss ≥ 1,000 ml; mean measured blood loss at 1, 2, and 24 h after delivery; death; requirement for blood transfusion; hemoglobin changes; and use of additional uterotonics. At 24 h postpartum, primary PPH occurred in 163 (28.6%) participants in the misoprostol group and 99 (17.4%) participants in the oxytocin group (relative risk [RR] 1.64, 95% CI 1.32 to 2.05, p<0.001; absolute risk difference 11.2%, 95% CI 6.44 to 16.1). Severe PPH occurred in 20 (3.6%) and 15 (2.7%) participants in the misoprostol and oxytocin groups, respectively (RR 1.33, 95% CI 0.69 to 2.58, p = 0.391; absolute risk difference 0.9%, 95% CI -1.12 to 2.88). Mean measured blood loss was 341.5 ml (standard deviation [SD] 206.2) and 304.2 ml (SD 190.8, p = 0.002) at 2 h and 484.7 ml (SD 213.3) and 432.8 ml (SD 203.5, p<0.001) at 24 h in the misoprostol and oxytocin groups, respectively. There were no significant differences between the two groups in any other secondary outcomes. Women in the misoprostol group more commonly experienced shivering (RR 1.91, 95% CI 1.65 to 2.21, p<0.001) and fevers (RR 5.20, 95% CI 3.15 to 7.21, p = 0.005). This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion. High-risk women were excluded from participation. CONCLUSIONS: Misoprostol 600 µg is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor. These data support use of oxytocin in settings where it is available. While not powered to do so, the study found no significant differences in rate of severe PPH, need for blood transfusion, postpartum hemoglobin, change in hemoglobin, or use of additional uterotonics between study groups. Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol. TRIAL REGISTRATION: ClinicalTrials.gov NCT01866241 Please see later in the article for the Editors' Summary.

Digital Adherence Technologies Linked to Mobile Money Incentives for Medication Adherence Among People Living With Tuberculosis: Mixed Methods Feasibility and Acceptability Study.

BACKGROUND: Complementing digital adherence technologies (DATs) with mobile money incentives may improve their utility in supporting tuberculosis medication adherence, yet the feasibility and acceptability of this integrated approach remain unclear. OBJECTIVE: This study aims to describe the feasibility and acceptability of a novel DAT intervention called My Mobile Wallet composed of real-time adherence monitoring, SMS text message reminders, and mobile money incentives for tuberculosis medication adherence in a low-income setting. METHODS: We purposively recruited people living with tuberculosis from the Mbarara Regional Referral Hospital in Mbarara, Uganda, who (1) were starting tuberculosis treatment at enrollment or within the past 4 weeks, (2) owned a mobile phone, (3) were able to use SMS test messaging, (4) were aged ≥18 years, and (5) were living in Mbarara district. At study exit (month 6), we used interviews and questionnaires informed by the unified theory of acceptance and use of technology (UTAUT) to collect feasibility and acceptability data, reflecting patients' experiences of using each component of My Mobile Wallet. Feasibility also included tracking the functionality of the adherence monitor (ie, an electronic pillbox) as well as SMS text message and mobile money delivery. We used a content analytical approach to inductively analyze qualitative data and Stata (version 13; StataCorp LLC) to analyze quantitative data. RESULTS: All 39 participants reported that the intervention was feasible because it was easy for them to use (eg, access and read SMS text messages) and worked as expected. Almost all SMS text messages (6880/7064, 97.4%) were sent as planned. The transmission of adherence data from the monitor worked well, with 98.37% (5682/5776) of the data transmitted as planned. All participants additionally reported that the intervention was acceptable because it helped them take their tuberculosis medication as prescribed; the mobile money incentives relieved them of tuberculosis-related financial burdens; SMS text message reminders and electronic pillbox-based alarms reminded them to take their medication on time; and participants perceived real-time adherence monitoring as "being watched" while taking their medication, which encouraged them to take their medication on time to demonstrate their commitment. The intervention was perceived as a sign of care, which eventually created emotional support and a sense of connectedness to health care. Participants preferred daily SMS text message reminders (32/39, 82%) to reminders linked to missed doses (7/39, 18%), citing the fact that tuberculosis medication is taken daily. CONCLUSIONS: The use of real-time adherence monitoring linked to SMS text message reminders and mobile money incentives for tuberculosis medication adherence was feasible and acceptable in a low-resource setting where poverty-based structural barriers heavily constrain tuberculosis treatment and care.

Labour Care Guide implementation as a decision-making tool for monitoring labour among healthcare providers in Uganda: protocol for a mixed-methods study.

INTRODUCTION: The new WHO Labour Care Guide (LCG), also regarded as the 'next-generation partograph', is a core component of 2018 WHO consolidated guidelines on intrapartum care for positive childbirth experience. The Ugandan Ministry of Health is in the process of adopting the new WHO LCG with no local context-specific data to inform this transition. We will explore potential barriers and facilitators to healthcare providers' (HCPs) sustained engagement in labour monitoring in Mbarara city, Southwestern Uganda, and use the data to refine the new WHO LCG and develop a suitable implementation strategy to effectively integrate LCG into routine maternity care in Uganda. We shall then assess effectiveness, validity and other preliminary implementation outcomes of using the new LCG in detecting prolonged labour. METHODS AND ANALYSIS: The study will use a mixed-methods approach to identify key LCG user perspectives to refine and customise the WHO LCG among 120 HCPs and stakeholders involved in maternity care and labour monitoring within facilities in Southwestern Uganda. The refined prototype will be deployed and used to monitor labour in all 14 basic and comprehensive emergency obstetric and newborn care facilities in the study area. We will review labour outcomes of 520 patients monitored using the new LCG and compare these outcomes with a historical cohort of 520 patients monitored using the partograph. The main effectiveness outcome will be the proportion of women diagnosed with prolonged labour and/or obstructed labour. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Mbarara University of Science and Technology Research Ethics Committee (MUST-2023-808) and Uganda National Council for Science and Technology (HS2864ES). We shall obtain written informed consent from each participant. The results of this study will be published in international peer-reviewed journals and presented to the Ugandan Ministry of Health as policy briefs and at selected national/international conferences. TRIAL REGISTRATION NUMBER: NCT05979194.

Prevalence and risk factors of chemotherapy-induced oral mucositis among adult cancer patients at the cancer unit of Mbarara Regional Referral Hospital.

BACKGROUND: Chemotherapy is a common treatment for cancer, but it is associated with adverse drug reactions like oral mucositis. This condition destroys basal cells in the oral mucosal layer, causing inflammation and ulceration. This can impact the patient's physical, emotional, and psychological well-being, affecting treatment outcomes and quality of life. This study aims to determine the prevalence, severity, and risk factors of chemotherapy-induced oral mucositis among adult cancer patients. METHODS: The study was a cross-sectional study conducted among adult cancer patients receiving chemotherapy at the cancer unit of Mbarara Regional Referral Hospital in southwestern Uganda. Data was collected through patient interviews, oral examinations, and patient chart reviews. RESULTS: Out of 268 patients, 115 (42.9%) experienced oral mucositis. Grade 2 oral mucositis was the most common (44.3%) followed by grade 1 (35.7%) and grade 3 (20.0%). Independent risk factors of chemotherapy-induced oral mucositis were female gender (Adjusted Odds Ratio (AOR) = 2.19, 95% confidence interval [CI]: 1.27-3.78; p-value = 0.005), poor oral hygiene (AOR = 3.70, 95% CI: 1.51-9.10; p-value = 0.04), and receiving chemotherapy containing an alkylating agent (AOR = 3.17, 95% CI: 1.63-6.19; p-value < 0.001). CONCLUSION: The study found that two out of five chemotherapy patients developed oral mucositis, with nearly half being grade 2. The risk factors identified in our study were comparable to those reported in previous studies. Therefore, identification and assessment of cancer patients at high risk for chemotherapy-induced oral mucositis should be routinely done for proper and timely management.

Customization and acceptability of the WHO labor care guide to improve labor monitoring among health workers in Uganda. An iterative development, mixed method study.

Cognisant of persistently high maternal and perinatal mortality rates, WHO called for adoption and evaluation of new adaptable and context-specific solutions to improve labor monitoring and health outcomes. We aimed at customizing/refining the new WHO labour care guide (LCG) to suite health care provider needs (HCP) in monitoring labour in Uganda. We used mixed methods to customize/refine and pilot test the new WHO LCG using stakeholder perspectives. Between 1st July 2023 and 30th December 2023, we conducted; 1)30 stakeholder interviews to identify user needs/challenges that informed initial modifications of the WHO LCG; 2)15 HCP in-depth interviews to identify any further needs to modify the LCG; 3) Two focus group discussions and 4) Two exit expert panels to identify any further user needs to further refine proposed modifications into the final prototype. Questionnaires were administered to assess acceptability. We interviewed 125 stakeholders with median age of 36 years (IQR;26-48) exposed to the LCG for at least 12 months with 11.8(SD = 4.6) years of clinical practice. Simple useful modifications/customizations based on format, HCP's perceived function and role in improving decision making during monitoring labour included; 1) Customizing LCG by adding key socio-demographic data; 2) Adjusting observation ordering; 3) Modification of medication dosages and 4) Provision for recording key clinical notes/labour outcome data on reverse side of the same A4 paper. All HCPs found the modified WHO LCG useful, easy to use, appropriate, comprehensive, appealing and would recommend it to others for labour monitoring. It was implementable and majority took less than 2 minutes to completely record/fill observations on the LCG after each labour assessment. Active involvement of end-users improved inclusiveness, ownership, acceptability and uptake. The modified LCG prototype was found to be simple, appropriate and easy-to-use. Further research to evaluate large-scale use, feasibility and effectiveness is warranted.

Development of a customized m-Health-based intervention to reduce loss to follow-up among patients undergoing treatment for cervical lesions at a rural referral Hospital, South Western Uganda.

Background: Loss to follow-up (LTFU) in individuals undergoing cervical cancer treatment is a major challenge in many low resource settings. We describe development of a customized and tailored mHealth intervention for reducing LTFU among patients undergoing cervical cancer treatment at Mbarara Regional Referral Hospital (MRRH). Methods: We interviewed all health care providers (HCPs) at the cervical cancer clinic of MRRH, between April and May 2023. Transcripts were subsequently derived, reviewed and coded to generate themes and categories using inductive content analytic approach. Four medical experts used this data to develop relevant SMS content, which was incorporated into an app. Results: HCPs had owned a phone for 13.8 ≤ years, had worked at the clinic for 5 ≤ years, and used text messages regularly. Qualitative data revealed that the main challenge to re-engagement was absence of a reminder mechanism between HCPs and patients. HCPs preferred text and or audio mode of messaging to improve health care responsiveness to LTFUs, awareness, continuity of care, and health service uptake among the majority illiterate population; though with potential constraints of costs and workload. Identified key messaging content included; the importance of attending scheduled follow-ups, follow up visit date and clinic customization and tailoring the message to the intended recipient. SMS content was uploaded onto the cc-follow-up app platform and customized according to preferred language, day, frequency and time of delivery. Conclusion: Tailoring an mHealth messaging intervention could help re-engage and reduce LTFU through improved information sharing, awareness, responsiveness, care engagement and medical compliance. A pilot study is required for our intervention in South Western Uganda.

Digital Adherence Technologies and Mobile Money Incentives for Management of Tuberculosis Medication Among People Living With Tuberculosis: Mixed Methods Formative Study.

BACKGROUND: Although there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT's utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear. OBJECTIVE: The aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting. METHODS: This study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants' cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data. RESULTS: Participants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication-related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential-not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic. CONCLUSIONS: DATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication. TRIAL REGISTRATION: ClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287.

Prevalence of postpartum depression and its association with Diabetes mellitus among mothers in Mbarara, southwestern Uganda.

Background: Postpartum Depression (PPD) is a major health challenge with potentially devastating maternal and physical health outcomes. Development of diabetes mellitus has been hypothesized as one the potential adverse effects of PPD among mothers in the postpartum period but this association has not been adequately studied. This study aimed at determining prevalence of postpartum depression and its association with diabetes mellitus among mothers in Mbarara District, southwestern Uganda. Methods: This was a facility based cross sectional study of 309 mothers between 6th week to 6th month after childbirth. Using proportionate stratified consecutive sampling, mothers were enrolled from postnatal clinics of two health facilities, Mbarara Regional Referral Hospital and Bwizibwera Health center IV. PPD was diagnosed using the Mini-International Neuropsychiatric Interview (MINI 7.0.2) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diabetes mellitus was diagnosed by measuring Hemoglobin A1c (HbA1c). Logistic regression was used to determine the association of PPD and diabetes mellitus among mothers. Results: The study established that PPD prevalence among mothers of 6th weeks to 6th months postpartum period in Mbarara was 40.5% (95% CI: 35.1-45.1%). A statistically significant association between postpartum depression and diabetes mellitus in mothers between 6 weeks and 6 months postpartum was established. The prevalence of diabetes mellitus among mothers with PPD was 28% compared to 13.6% among mothers without PPD Mothers with PPD had 3 times higher odds of being newly diagnosed with diabetes between 6 weeks and 6 months postpartum as compared to those without PPD during the same period (aOR=3.0, 95% CI: 1.62-5.74, p=0.001). Conclusion and Recommendations: Postpartum women within 6th weeks to 6th months have higher risks of developing diabetes mellitus. Research is needed to determine if targeted diabetes mellitus screening, prevention interventions and management will help reduce the burden.