Expanding the Evidence on the Safety and Efficiency of 2-Way Text Messaging-Based Telehealth for Voluntary Medical Male Circumcision Follow-up Compared With In-Person Reviews: Randomized Controlled Trial in Rural and Urban South Africa.

BACKGROUND: There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries. We previously conducted a randomized controlled trial (RCT) in Zimbabwe, demonstrating that 2-way texting (2wT) was safe and effective for follow-up after adult voluntary medical male circumcision (VMMC). OBJECTIVE: To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Africa to determine whether 2wT improves adverse event (AE) ascertainment and, therefore, the quality of follow-up after VMMC while reducing health care workers' workload. METHODS: A prospective, unblinded, noninferiority RCT was conducted among adult participants who underwent VMMC with cell phones randomized in a 1:1 ratio between 2wT and control (routine care) in North West and Gauteng provinces. The 2wT participants responded to a daily SMS text message with in-person follow-up only if desired or an AE was suspected. The control group was requested to make in-person visits on postoperative days 2 and 7 as per national VMMC guidelines. All participants were asked to return on postoperative day 14 for study-specific review. Safety (cumulative AEs ≤day 14 visit) and workload (number of in-person follow-up visits) were compared. Differences in cumulative AEs were calculated between groups. Noninferiority was prespecified with a margin of -0.25%. The Manning score method was used to calculate 95% CIs. RESULTS: The study was conducted between June 7, 2021, and February 21, 2022. In total, 1084 men were enrolled (2wT: n=547, 50.5%, control: n=537, 49.5%), with near-equal proportions of rural and urban participants. Cumulative AEs were identified in 2.3% (95% CI 1.3-4.1) of 2wT participants and 1.0% (95% CI 0.4-2.3) of control participants, demonstrating noninferiority (1-sided 95% CI -0.09 to ∞). Among the 2wT participants, 11 AEs (9 moderate and 2 severe) were identified, compared with 5 AEs (all moderate) among the control participants-a nonsignificant difference in AE rates (P=.13). The 2wT participants attended 0.22 visits, and the control participants attended 1.34 visits-a significant reduction in follow-up visit workload (P<.001). The 2wT approach reduced unnecessary postoperative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among the 2wT participants, 94% (514/547) responded to ≥1 daily SMS text messages over 13 days. CONCLUSIONS: Across rural and urban contexts in South Africa, 2wT was noninferior to routine in-person visits for AE ascertainment, demonstrating 2wT safety. The 2wT approach also significantly reduced the follow-up visit workload, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of the 2wT telehealth approach to other acute follow-up care contexts could extend these gains beyond VMMC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04327271; https://www.clinicaltrials.gov/ct2/show/NCT04327271.

Centering healthcare workers in digital health design: Usability and acceptability of two-way texting to improve retention in antiretroviral therapy in a public HIV clinic in Lilongwe, Malawi.

New initiates on antiretroviral therapy (ART) are at high risk of treatment discontinuation, putting their health at risk. In low- and middle-income countries, like Malawi, appropriate digital health applications (apps) must fit into local clinic, connectivity and resource constraints. We describe the human centered design (HCD) and development process of an open-source, hybrid, two-way texting (2wT) system to improve ART retention. We detail the critical role of diverse healthcare workers (HCWs) in the HCD process to inform app usability, create buy-in, and ensure appropriate optimization for the local context. We optimized 2wT usability and acceptability over three HCD phases: 1) informal feedback sessions with diverse 2wT stakeholders, 2) a small pilot, and 3) key informant interviews. Phase one included four sessions with diverse HCWs, including "expert ART clients", clinical, technical, supervisory, and evaluation teams to inform 2wT design. In phase 2, a small pilot with 50 participating ART clients aimed to inform implementation improvement. Phase three included interviews with ten HCWs to deepen understanding of 2wT acceptability and usability, documenting strengths and weaknesses to inform optimization. Multi-phase feedback sessions with HCWs helped refine 2wT language and message timing for both weekly and tailored client-specific visit reminders. The pilot led to improvements in educational materials to guide client responses and ease interaction with HCWs. In interviews, the HCWs appreciated the HCD co-creation process, suggested ways to increase access for low-literacy clients or those without consistent phone access, and felt integrating 2wT with other eHealth platforms would improve scalability. Inclusion of HCWs across phases of HCD design, adaption, and optimization increased 2wT usability and acceptability among HCWs in this setting. Engaging HCWs into 2wT co-ownership from inception appears successful in co-creation of an app that will meet HCW needs, and therefore, enhance support for 2wT clients to attend visits and remain in care.

Centering healthcare workers in developing digital health interventions: usability and acceptability of a two-way texting retention intervention in a public HIV clinic in Lilongwe, Malawi.

Background: New initiates on antiretroviral therapy (ART) are at high risk of treatment discontinuation, putting their health at risk. In low-resource settings, like Malawi, appropriate digital health applications must fit into local connectivity and resource constraints. Target users' perspectives are critical for app usability, buy-in and optimization. We describe the formative stages of the design of a two-way text-based (2wT) system of tailored reminders and adherence messages for new ART initiates and share results from key informant interviews with HCWs focused on app usability and acceptability. Methods: Using a co-creation approach with clients, clinical, technical and evaluation teams and over app development, we held four informal user feedback sessions, a small pilot with 50 clients, and ten key informant (KIIs) to deepen our understanding of healthcare workers (HCWs) needs, acceptability and usability. Results: Formative research informed the design of interactive client-to-HCW communication, refining of the language and timing of weekly text blast motivational messages and tailored client-specific visit reminders. Informal feedback from HCW stakeholders also informed educational materials to enhance 2wT client understanding of how to report transfers, request visit date changes and ask questions related to their visits. In KII, HCWs noted their appreciation for the co-creation process, believing that the participatory HCD process and responsive design team enabled the development of a highly acceptable and usable 2wT digital tool. HCWs also suggested future improvements to promote inclusion of clients of varying literacy levels and economic backgrounds as well as integrating with other health platforms to improve uptake of 2wT. Conclusions: Inclusion of HCWs increased perceptions of app usability and acceptability among HCWs. HCWs believe that 2wT will improve on-time ART visit attendance and provide valuable early retention in care support. The co-creation approach appears successful in designing an app that will meet HCW needs and, therefore, support client adherence to visits.

A Community-Based, Mobile Electronic Medical Record System App for High-Quality, Integrated Antiretroviral Therapy in Lilongwe, Malawi: Design Process and Pilot Implementation.

BACKGROUND: Differentiated service delivery (DSD) increases antiretroviral therapy (ART) access in sub-Saharan Africa by moving clients out of congested ART clinics to communities for care. However, DSD settings challenge provider adherence to complex, chronic care treatment guidelines and have burdensome systems for client monitoring and evaluation (M&E), reducing data for decision-making. Electronic medical record systems (EMRS) improve client outcomes and reduce M&E workload. Traditional EMRS cannot operate in most DSD settings with unreliable power and poor connectivity. OBJECTIVE: This study aims to detail the human-centered design (HCD) process of developing a mobile EMRS for community-based DSD services in Lilongwe, Malawi. METHODS: Lighthouse Trust (LT) operates 2 Ministry of Health (MoH) clinics in Lilongwe, Malawi, with a combined total of >35,000 ART clients. LT's real-time, point-of-care EMRS collects complex client M&E data and provides decision-making support, ensuring adherence to integrated HIV and tuberculosis guidelines that optimize client and program outcomes. LT's EMRS scaled to all large MoH ART clinics. LT also implements a nurse-led community-based ART program (NCAP), a DSD model to provide ART and rapid assessment for 2400 stable LT clients in the community. LT, alongside collaborators, from the University of Washington's International Training and Education Center for Health and technology partner, Medic, used the open-source Community Health Toolkit (CHT) and HCD to develop an open-source, offline-first, mobile EMRS-like app, "community-based ART retention and suppression" (CARES). CARES aims to bring EMRS-like provider benefits to NCAP's DSD clients. RESULTS: CARES design took approximately 12 months and used an iterative process of highly participatory feedback sessions with provider, data manager, and M&E team inputs to ensure CARES optimization for the NCAP and LT settings. The CARES mobile EMRS prototype supports NCAP providers with embedded prompts and alerts to ensure adherence to integrated MoH ART guidelines, aiming to improve the quality of client care. CARES facilitates improved data quality and flow for NCAP M&E, aiming to reduce data gaps between community and clinic settings. The CARES pilot demonstrates the potential of a mobile, point-of-care EMRS-like app that could benefit NCAP clients, providers, and program teams with integrated client care and complete M&E data for decision-making. CARES challenges include app speed, search features to align longitudinal records, and CARES to EMRS integration that supports timely care alerts. CONCLUSIONS: Leveraging the CHT and HCD processes facilitated the design of a locally specified and optimized mobile app with the promise to bring EMRS-like benefits to DSD settings. Moving from the CARES prototype to routine NCAP implementation should result in improved client care and strengthened M&E while reducing workload. Our transparent and descriptive process shares the progress and pitfalls of the CARES design and development, helping others in this digital innovation area to learn from our experiences at this stage.

Women's groups and COVID-19: An evidence review on savings groups in Africa.

The coronavirus disease 2019 (COVID-19) pandemic and some of the associated policy responses have resulted in significant gendered impacts that may reverse recent progress in gender equality, including in sub-Saharan Africa. This paper presents emerging evidence from studies in diverse contexts in sub-Saharan Africa -with a deep dive into Nigeria and Uganda-on how COVID-19 has affected women's groups, especially savings groups, and how these groups have helped mitigate the gendered effects of the pandemic's and the associated policy responses' consequences up until April 2021. The synthesis presents evidence that savings groups found ways to continue operating, provided leadership opportunities for women during the pandemic, and mitigated some of the negative economic consequences of COVID-19 on individual savings group members. Savings, credit, and group support from other members all likely contributed to the ability of groups to positively affect the resilience of women's group member during COVID-19. Households with a female member in a savings group in Nigeria and Uganda have coped with the crisis better than those not in savings groups. While savings groups have shown the potential for resilience during the pandemic, they often faced financial challenges because of decreased savings, which sometimes resulted in the depletion of group assets. Savings groups also contributed to community responses and provided women a platform for leadership. These findings are consistent with a recent evidence synthesis on how past covariate shocks affected women's groups and their members. We conclude the paper by presenting various policy recommendations to enable savings groups to achieve improvements in women's empowerment and economic outcomes, and research recommendations to address some of the current evidence gaps on how COVID-19 is affecting women's groups and their members.

Evaluation of the impact of news coverage of an HIV multiclass drug-resistant cluster in Seattle, Washington.

OBJECTIVES: In February 2007, Public Health-Seattle and King County issued a press release describing a cluster of multiclass drug-resistant HIV cases among men who had sex with men (MSM). We evaluated the effect of the press release among MSM in the Seattle area. METHODS: We administered a rapid assessment survey at venues where MSM congregate. Eligible participants were men who had sex with men in the past year, were older than 18 years, and were residents of western Washington State. RESULTS: Among 325 participants, 57% heard or saw messages related to the press release. Of these, 87% remembered 1 or more key points, but only 5% remembered key prevention messages. Ninety-eight percent of participants thought it was important for the health department to get the message out about drug-resistant HIV. CONCLUSIONS: The press release was found to be a useful and well-received method to inform the public about an HIV drug-resistant cluster. Low retention and nonprominent coverage of key prevention messages suggests that health departments using press releases as a prevention tool need to carefully consider placement and emphasis of those messages in a press statement.

Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies.

OBJECTIVE: To evaluate the performance of a rapid HIV antibody test used with whole blood and oral fluid in settings where the test is likely to be used. DESIGN: In four separate studies, we compared the accuracy of the rapid test performed on whole blood and oral fluid specimens with the results of conventional HIV tests. METHODS: Oral fluid and whole blood from persons of unknown HIV status recruited from clinics, labor and delivery units, and outreach venues were tested with the OraQuick Advance rapid HIV-1/2 antibody test. Sensitivity and specificity were compared with results of the enzyme immunoassay (EIA) and Western blot algorithm used by the study sites. RESULTS: OraQuick sensitivity was 99.7% with whole blood and 99.1% with oral fluid from 327 persons who were HIV antibody positive by the conventional algorithm. OraQuick specificity was 99.9% with whole blood and 99.6% with oral fluid from 12 010 HIV-negative persons; EIA specificity was 99.7%. A cluster of 16 false-positive oral fluid tests occurred in one study, in which specificity was lower (99.0%) than in the other three studies (99.6-99.8%). CONCLUSIONS: In diverse settings in four studies, the OraQuick test showed high sensitivity and specificity for HIV antibody in whole blood and oral fluid specimens. Slightly more false-positive and false-negative results occurred with oral fluid than with whole blood, but performance with both specimen types was similar to, or better than, that of conventional EIAs.

Revitalizing long-acting reversible contraceptives in settings with high unmet need: a multicountry experience matching demand creation and service delivery.

BACKGROUND: Contraception in many developing countries is characterized by high unmet need, irregular access, low utilization and presumed demand for long-acting reversible contraceptives (LARCs). STUDY DESIGN: A 13-country initiative focused on increasing consumer demand and high quality services for intrauterine devices (IUDs) began in 2009. Services were provided through (a) private sector-franchised or affiliated clinics; (b) providers seconded to the public sector and (c) special "event" days. Client intake data are used to compare the profile of IUD acceptors with IUD users from representative national datasets of select countries, as well as examine trends in IUD uptake. RESULTS: During 2009-2010, 575,601 IUDs were inserted across the 13 countries. Compared to national IUD users, users in this project were slightly younger and less educated. Among IUD acceptors, 24% used no modern method at the time of IUD initiation, and 28% reported injectable use in the three previous months. CONCLUSIONS: Convenient, quality, affordable services with demand creation can result in significant uptake of LARCs in settings with low use.

Condom social marketing in sub-Saharan Africa and the Total Market Approach.

BACKGROUND: Social marketing interventions are important in developing nations. Both increasing use and shifting users from receiving subsidised condoms need to be pursued using a Total Market Approach (TMA). This paper reviews the performance of social marketing through a cross-country comparison of condom use, equity and market share, plus a case study illustrating how TMA can be applied. METHODS: Demographic and Health Survey data (1998-2007) provide condom use trends, concentration indices and sources of supply by gender for 11 African countries. Service delivery information and market research provide market share data for the same period. For the case study, two-yearly surveys (2001-09) are the source of condom trends, and retail audit data (2007-09) provide sustainability data. RESULTS: Among women, condom use with a non-marital, non-cohabiting partner increased significantly in 7 of 11 countries. For men, 5 of 11 countries showed an increase in condom use. Equity improved for men in five countries and was achieved in two; for women, equity improved in three. Most obtained condoms from shops and pharmacies; social marketing was the dominant source of supply. Data from Kenya were informative for TMA, showing improvements in condom use over time, but sustainability results were mixed and equity was not measured. Overall market value and number of brands increased; however, subsidies increased over time. CONCLUSIONS: Condom social marketing interventions have advanced and achieved the goals of improving use and making condoms available in the private sector. It is time to manage interventions and influence markets to improve equity and sustainability.

HIV transmission in a state prison system, 1988-2005.

INTRODUCTION: HIV prevalence among state prison inmates in the United States is more than five times higher than among nonincarcerated persons, but HIV transmission within U.S. prisons is sparsely documented. We investigated 88 HIV seroconversions reported from 1988-2005 among male Georgia prison inmates. METHODS: We analyzed medical and administrative data to describe seroconverters' HIV testing histories and performed a case-crossover analysis of their risks before and after HIV diagnosis. We sequenced the gag, env, and pol genes of seroconverters' HIV strains to identify genetically-related HIV transmission clusters and antiretroviral resistance. We combined risk, genetic, and administrative data to describe prison HIV transmission networks. RESULTS: Forty-one (47%) seroconverters were diagnosed with HIV from July 2003-June 2005 when voluntary annual testing was offered. Seroconverters were less likely to report sex (OR [odds ratio] = 0.02, 95% CI [confidence interval]: 0-0.10) and tattooing (OR = 0.03, 95% CI: <0.01-0.20) in prison after their HIV diagnosis than before. Of 67 seroconverters' specimens tested, 33 (49%) fell into one of 10 genetically-related clusters; of these, 25 (76%) reported sex in prison before their HIV diagnosis. The HIV strains of 8 (61%) of 13 antiretroviral-naïve and 21 (40%) of 52 antiretroviral-treated seroconverters were antiretroviral-resistant. DISCUSSION: Half of all HIV seroconversions were identified when routine voluntary testing was offered, and seroconverters reduced their risks following their diagnosis. Most genetically-related seroconverters reported sex in prison, suggesting HIV transmission through sexual networks. Resistance testing before initiating antiretroviral therapy is important for newly-diagnosed inmates.

Willingness of men who have sex with men (MSM) in the United States to be circumcised as adults to reduce the risk of HIV infection.

BACKGROUND: Circumcision reduces HIV acquisition among heterosexual men in Africa, but it is unclear if circumcision may reduce HIV acquisition among men who have sex with men (MSM) in the United States, or whether MSM would be willing to be circumcised if recommended. METHODS: We interviewed presumed-HIV negative MSM at gay pride events in 2006. We asked uncircumcised respondents about willingness to be circumcised if it were proven to reduce risk of HIV among MSM and perceived barriers to circumcision. Multivariate logistic regression was used to identify covariates associated with willingness to be circumcised. RESULTS: Of 780 MSM, 133 (17%) were uncircumcised. Of these, 71 (53%) were willing to be circumcised. Willingness was associated with black race (exact odds ratio [OR]: 3.4, 95% confidence interval [CI]: 1.3-9.8), non-injection drug use (OR: 6.1, 95% CI: 1.8-23.7) and perceived reduced risk of penile cancer (OR: 4.7, 95% CI: 2.0-11.9). The most commonly endorsed concerns about circumcision were post-surgical pain and wound infection. CONCLUSIONS: Over half of uncircumcised MSM, especially black MSM, expressed willingness to be circumcised. Perceived risks and benefits of circumcision should be a part of educational materials if circumcision is recommended for MSM in the United States.

Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test.

BACKGROUND: In March 2004, the OraQuick rapid HIV antibody test became the first rapid HIV test approved by the US Food and Drug Administration for use on oral fluid specimens. Test results are available in 20 minutes, and the oral fluid test is non-invasive. From August 2004-June 2005, we investigated a sudden increase in false-positive results occurring in a performance study of OraQuick oral-fluid rapid HIV tests in Minnesota. METHODOLOGY/PRINCIPAL FINDINGS: In a field investigation, we reviewed performance study data on oral-fluid and whole-blood OraQuick rapid HIV test device lots and expiration dates and assessed test performance and interpretation with oral-fluid and whole-blood specimens by operators who reported false-positive results. We used multivariate logistic regression to evaluate client demographic and risk characteristics associated with false-positive results. Next, we conducted an incidence study of false-positive OraQuick rapid HIV tests in nine US cities and tested both oral-fluid and finger-stick whole-blood specimens from clients; reactive tests were confirmed with Western blot. Sixteen (4.1%) false-positive oral-fluid results occurred in the performance study from April 15, 2004 through August 31, 2004 with unexpired devices from six test lots among 388 HIV-uninfected clients (specificity, 95.9%; 95% CI: 93.4-97.6). Three test operators who had reported false-positive results performed and interpreted the test according to package-insert instructions. In multivariate analysis, only older age was significantly associated with false-positive results (adjusted odds ratio = 4.5, 95% CI: 1.2-25.7). In the incidence study, all valid oral-fluid and whole-blood results from 2,268 clients were concordant and no false-positive results occurred (100% specificity). CONCLUSIONS/SIGNIFICANCE: The field investigation did not identify a cause for the increase in false-positive oral-fluid results, and the incidence study detected no false-positive results. The findings suggest this was an isolated cluster; the test's overall performance was as specified by the manufacturer.