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1.
Clin Infect Dis ; 2024 Apr 24.
Article in English | MEDLINE | ID: mdl-38657086

ABSTRACT

BACKGROUND: Women in Africa disproportionately acquire HIV-1. Understanding which women are most likely to acquire HIV-1 can guide focused prevention with pre-exposure prophylaxis (PrEP). Our objective is to identify women at highest risk of HIV-1 and estimate PrEP efficiency at different sensitivity levels. METHODS: Nationally representative data were collected from 2015-2019 from 15 population-based household surveys. This analysis included women aged 15-49 who tested HIV-1 sero-negative or had recent HIV-1. Least absolute shrinkage and selection operator regression models were fit with 28 variables to predict recent HIV-1. Models were trained on the full population and internally cross-validated. Performance was evaluated using area under the receiver-operating-characteristic curve (AUC), sensitivity, and number needed to treat (NNT) with PrEP to avert one infection. RESULTS: Among 209,012 participants 248 had recent HIV-1 infection, representing 118 million women and 402,000 (95% CI: 309,000-495,000) new annual infections. Two variables were retained in the model: living in a subnational area with high HIV-1 viremia and having a sexual partner living outside the home. Full-population AUC was 0.80 (95% CI: 0.76-0.84); cross-validated AUC was 0.79 (95% CI: 0.75-0.84). At a sensitivity of 33%, up to 130,000 cases could be averted if 7.9 million women were perfectly adherent to PrEP; NNT would be 61. At a sensitivity of 67%, up to 260,000 cases could be averted if 25.1 million women were perfectly adherent to PrEP; the NNT would be 96. CONCLUSIONS: This risk assessment tool was generalizable, predictive, and parsimonious with tradeoffs between reach and efficiency.

2.
Am J Epidemiol ; 2024 Jul 11.
Article in English | MEDLINE | ID: mdl-38992859

ABSTRACT

In sub-Saharan Africa, adolescent girls and young women aged 15-24 (AGYW) experience high risk of early and unintended pregnancy. We assessed the impact of youth-friendly health services (YFHS) on pregnancy risk among AGYW who participated in the Girl Power study. In 2016, Girl Power randomly assigned four government-run health centers in Lilongwe, Malawi, to provide a standard (n=1) or youth-friendly (n=3) model of service delivery. At six and 12 months, study participants (n=250 at each health center) self-reported their current pregnancy status and received a urine pregnancy test. Because of missing pregnancy test results, we used multiple imputation to correct for outcome misclassification in self-reported pregnancy status, and applied the parametric g-formula on the corrected data to estimate the effect of YFHS on the 12-month risk of pregnancy. After correcting for outcome misclassification, the risk of pregnancy under the scenario where all health centers offered YFHS was 15.8% compared to 23.2% under the scenario where all health centers offered standard of care (risk difference: -7.3%, 95% CI: -15.5%, 0.8%). Access to a model of YFHS that integrates provider training with youth-friendly clinic modifications and community outreach activities may decrease risk of pregnancy among AGYW relative to standard of care.

3.
BMC Health Serv Res ; 24(1): 606, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38720312

ABSTRACT

BACKGROUND: Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining "assisting" health care workers' experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility. METHODS: In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers' experiences counseling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team. RESULTS: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers. CONCLUSIONS: Maximizing assisted ICT's potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT. TRIAL REGISTRATION: NCT05343390. Date of registration: April 25, 2022.


Subject(s)
Feasibility Studies , HIV Infections , Qualitative Research , Humans , Malawi , HIV Infections/diagnosis , Female , Male , Adult , Interviews as Topic , HIV Testing/methods , Contact Tracing/methods , Community Health Workers
4.
AIDS Behav ; 27(12): 4022-4032, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37392270

ABSTRACT

In two parallel pilot studies, we implemented a combination adherence intervention of patient-centered counselling and adherence supporter training, tailored to support HIV treatment (i.e., antiretroviral therapy) or prevention (i.e., pre-exposure prophylaxis, or PrEP) during pregnancy and breastfeeding. Using a mixed-methods approach, we evaluated the intervention's acceptability. We investigated engagement, satisfaction, and discussion content via survey to all 151 participants assigned to the intervention arm (51 women living with HIV, 100 PrEP-eligible women without HIV). We also conducted serial in-depth interviews with a subgroup (n = 40) at enrollment, three months, and six months. In the quantitative analysis, the vast majority reported high satisfaction with intervention components and expressed desire to receive it in the future, if made available. These findings were supported in the qualitative analysis, with favorable comments about counselor engagement, intervention content and types of support received from adherence supporters. Overall, these results demonstrate high acceptability and provide support for HIV status-neutral interventions for antiretroviral adherence.


Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Pregnancy , Humans , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Pre-Exposure Prophylaxis/methods , Malawi/epidemiology , Breast Feeding , Anti-Retroviral Agents/therapeutic use
5.
AIDS Behav ; 27(Suppl 1): 116-127, 2023 May.
Article in English | MEDLINE | ID: mdl-35829970

ABSTRACT

Engagement of adolescents and young adults (AYA) in HIV research is increasing in many settings. We organized a crowdsourcing open call to solicit examples of how AYA have been engaged in HIV research in Africa and to develop an engagement typology. We formed a steering committee, promoted the open call, organized judging and recognized finalists. We used a multi-methods approach to identify emerging themes and measure engagement. We received 95 entries from individuals in 15 countries; 74 met the eligibility criteria. More than three-quarters of entries were from AYA (55/74, 74%). Four themes characterized AYA engagement: (1) AYA were co-creators in the HIV research process. (2) AYA were involved in community-level capacity building. (3) AYA were co-leaders in minor risk research. (4) AYA used digital methods to enhance engagement. Our open call identified diverse methods of AYA engagement, which can enhance strategies used to reach AYA in African HIV studies.


Subject(s)
Crowdsourcing , HIV Infections , Humans , Adolescent , Young Adult , HIV Infections/epidemiology , HIV Infections/prevention & control , Africa South of the Sahara/epidemiology
6.
BMC Womens Health ; 23(1): 478, 2023 09 09.
Article in English | MEDLINE | ID: mdl-37689628

ABSTRACT

INTRODUCTION: In 2018, the Malawi Ministry of Health adopted the recommendation to switch first-line antiretroviral therapy (ART) from an efavirenz (EFV)-based to a dolutegravir (DTG)-based regimen. Little is known about patients' experience during this transition. We conducted a qualitative study to explore DTG-related counselling challenges among providers of HIV care and factors influencing regimen switching or non-switching among women living with HIV in Lilongwe, Malawi. METHODS: Between February-July 2020, we recruited participants who took part in DTG counselling on reasons to switch, side effects, and benefits from two government health facilities providing HIV care: Area 18 health centre and Bwaila district hospital in Lilongwe, Malawi. We purposively sampled and interviewed 8 women living with HIV who remained on an EFV-based regimen after counselling, 10 women who switched to a DTG-based regimen, and 10 HIV care providers who provided counselling about ART switching. In-depth interviews were used to explore patient's perceptions of DTG, factors affecting the decision to switch, and both patient and provider experience with counselling. Interview data was coded for themes using inductive and deductive codes. Interviews were conducted until thematic saturation was achieved. Data matrices were used for analysis and thematic extraction. RESULTS: Most women in both groups were well versed on DTG's potential side effects and felt well counselled on the benefits of switching, such as quicker viral load suppression. Many women associated DTG with birth defects and expressed concern. However, the primary reason for not switching was concern with how the new medication would be tolerated, especially when they were satisfied with their current regimen. Almost all providers expressed difficulty providing DTG counselling. Primary reasons included feeling inadequately trained and/or not having resources to use during counselling, such as diagrams or brochures. CONCLUSION: DTG counselling was well accepted by women; however, some felt that their concerns were not fully addressed. Providers reflected this sentiment in that they did not feel adequately trained or well-equipped to provide adequate counselling. Training on counselling for new ART regimens should be intensified and utilize patient-centered educational materials to address the concerns raised by both patients and health care providers.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , HIV Infections , Humans , Female , Benzoxazines , Counseling , Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy
7.
AIDS Behav ; 26(3): 822-832, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34426863

ABSTRACT

Transactional sex increases HIV risk among adolescent girls and young women (AGYW). Understanding the individual and dyadic nature of transactional sex may provide evidence for risk reduction interventions. Multilevel logistic regression was used to cross-sectionally examine correlates of transactional sex among AGYW in Lilongwe, Malawi. Participants (N = 920) reported 1227 relationships. Individual-level associations were found between being divorced/widowed (AOR 5.07, 95% CI 1.93, 13.25), married (AOR 0.26, 95% CI 0.09, 0.72), or unstably housed (AOR 7.11, 95% CI 2.74, 18.47) and transactional sex. At the relationship-level, transactional sex occurred in relationships with: non-primary primary partners (AOR 4.06, 95% CI 2.37, 6.94), perceived partner concurrency (AOR 1.85, 95% CI 1.11, 3.08), and feared violence with couples HIV testing (AOR 2.81, 95% CI 1.26, 6.29), and less likely to occur in relationships with children (AOR 0.15, 95% CI 0.06, 0.38). Multiple co-occurring social and structural vulnerabilities increase transactional sex engagement warranting the need for social protection and gender transformative approaches.


Subject(s)
HIV Infections , Adolescent , Child , Female , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Malawi/epidemiology , Multilevel Analysis , Sexual Behavior , Sexual Partners , Violence
8.
BMC Infect Dis ; 21(1): 505, 2021 May 31.
Article in English | MEDLINE | ID: mdl-34059014

ABSTRACT

BACKGROUND: Youth are at high risk for HIV, but are often left out of designing interventions, including those focused on adolescents. We organized a designathon for Nigerian youth to develop HIV self-testing (HIVST) strategies for potential implementation in their local communities. A designathon is a problem-focused event where participants work together over a short period to create and present solutions to a judging panel. METHODS: We organized a 72-h designathon for youth (14-24 years old) in Nigeria to design strategies to increase youth HIVST uptake. Proposals included details about HIVST kit service delivery, method of distribution, promotional strategy, and youth audience. Teams pitched their proposals to a diverse seven-member judging panel who scored proposals based on desirability, feasibility, potential impact and teamwork. We examined participants' socio-demographic characteristics and summarized themes from their HIVST proposals. RESULTS: Forty-two youth on 13 teams participated in the designathon. The median team size was 3 participants (IQR: 2-4). The median age was 22.5 years (IQR: 21-24), 66.7% were male, 47.4% completed tertiary education, and 50% lived in Lagos State. Themes from proposals included HIVST integration with other health services, digital marketing and distribution approaches, and engaging students. Judges identified seven teams with exceptional HIVST proposals and five teams were supported for further training. CONCLUSIONS: The designathon provided a structured method for incorporating youth ideas into HIV service delivery. This approach could differentiate HIV services to be more youth-friendly in Nigeria and other settings.


Subject(s)
Community Health Services/methods , HIV Infections/diagnosis , Mass Screening/methods , Self-Testing , Adolescent , Delivery of Health Care , Female , Humans , Male , Nigeria , Young Adult
9.
Stud Fam Plann ; 52(4): 397-413, 2021 12.
Article in English | MEDLINE | ID: mdl-34585384

ABSTRACT

In sub-Saharan Africa, adolescent girls and young women (AGYW) have high levels of unmet need for contraception, particularly those who are unmarried or nulliparous. Conversations with partners, peers, and family members influence AGYW contraceptive decision-making yet little is known about conversation content and impact or how they vary by relationship status and parity. This paper draws on qualitative data from 60 AGYW (aged 15-24) participating in a sexual and reproductive health study in Malawi to examine contraceptive conversation patterns among participants and their social ties. AGYW's relationship status and parity influenced whether they talked about contraceptives, who they talked to about contraceptives, and the type of contraceptives that were endorsed during conversations. Unmarried and nulliparous AGYW were less likely to discuss contraceptives with all social ties and when conversations occurred, norms and misinformation regarding nonbarrier methods were reinforced, and condoms were largely prescribed. Conversations with intimate partners often provided permission for contraceptive use while conversations with peers and older women in the family provided information on contraceptive methods. Our results highlight the unique roles that social ties play in AGYW contraceptive decision-making and suggest that existing contraceptive conversation patterns might exclude unmarried, nulliparous AGYW from accurate and comprehensive contraceptive information and options.


Subject(s)
Contraception , Contraceptive Agents , Adolescent , Aged , Communication , Contraception Behavior , Family , Female , Humans , Malawi , Pregnancy
10.
Women Health ; 61(5): 440-451, 2021.
Article in English | MEDLINE | ID: mdl-33941050

ABSTRACT

In Malawi, 50% of adolescent girls and young women (AGYW) have had a first child by age 19 and 45% report their pregnancies as unintended or mistimed. Yet, uptake of contraception remains low. Understanding how interactions with social ties impact AGYW contraceptive use might explain low uptake beyond individual and environmental factors. Data are from Girl-Power, a study among sexually active AGYW, aged 15-24, in Malawi. We used logistic regression models to examine whether contraceptive communication and social norms (descriptive and injunctive) were associated with contraceptive use (non-barrier methods and condoms) and how associations differed across social ties (older women in the family, peers, and partners). The sample included 942 participants: 28% reported using non-barrier methods and 66% reported using condoms. Contraceptive communication with older women in the family (aOR: 1.48, 95% CI: 0.99, 2.20), peers (aOR: 3.12, 95% CI: 1.96, 4.96), and partners (aOR 5.15, 95% CI: 3.13, 8.48) was associated with non-barrier method use. Descriptive norms were associated with non-barrier methods among peers (aOR 2.57, 95% CI: 1.63, 4.96) but not among older women in the family (aOR: 1.22, 95% CI 0.80, 1.88). There were no associations among contraceptive communication, social norms, and condom use across older women in the family, peers, and partners. The findings highlight the need to consider the influence of social ties in the design of future family planning interventions and suggest that interventions that encourage interpersonal communication about contraception and target peer-based descriptive norms have the potential to impact uptake of non-barrier methods.


Subject(s)
Contraceptive Agents , Social Norms , Adolescent , Communication , Condoms , Contraception , Contraception Behavior , Female , Humans , Infant, Newborn , Malawi , Pregnancy , Young Adult
11.
Sex Transm Dis ; 47(11): 760-766, 2020 11.
Article in English | MEDLINE | ID: mdl-33045165

ABSTRACT

BACKGROUND: Prioritizing HIV prevention for adolescent girls and young women (AGYW) at high risk for HIV acquisition in sub-Saharan Africa (typically considered ≥3 per 100 person-years [PYs]) is urgently needed, but identifying these AGYW is challenging. We sought to assess and, if needed, enhance a risk assessment tool from the VOICE trial for identifying AGYW at high risk for HIV in Lilongwe, Malawi. METHODS: A multisite prospective cohort study was conducted among sexually active AGYW 15 to 24 years old at 4 health centers in 2016 to 2017. The VOICE tool was first applied and then updated by excluding variables that were not predictive and adding variables that were. Incidence rates (IRs), incidence rate ratios, 95% confidence intervals (CIs), area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were calculated. RESULTS: Seven hundred ninety-five participants experienced 14 seroconversions for 672 PYs (IR, 2.08 per 100 PYs; 95% CI, 1.23-3.52). The VOICE tool had moderate predictive ability (AUC, 0.64; 95% CI, 0.52-0.75). Maintaining 2 variables (genital ulcers and vaginal discharge), removing 5 sociodemographic variables, and adding 2 variables (ever pregnant and >5-year male-female age gap) enhanced performance (AUC, 0.79; 95% CI, 0.69-0.89). Thirty-five percent had a score of 0, 41% had a score of 1 to 2, and 24% had a score >3. A score >1 resulted in 100% sensitivity, 35.9% specificity, and an IR of 3.25 per 100 PYs. A score >3 resulted in 64.3% sensitivity, 76.8% specificity, and an IR of 5.89 per 100 PYs. CONCLUSIONS: A simple risk assessment tool identified a subset of AGYW in Malawi at high risk for HIV acquisition who may benefit from biomedical HIV prevention.


Subject(s)
HIV Infections/prevention & control , HIV Infections/psychology , Risk Assessment/methods , Sexually Transmitted Diseases/prevention & control , Adolescent , Adult , Condoms/statistics & numerical data , Female , HIV Infections/epidemiology , HIV Infections/transmission , Humans , Incidence , Malawi/epidemiology , Male , Prospective Studies , Risk Factors , Sexual Behavior/statistics & numerical data , Sexual Partners , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/psychology , Sexually Transmitted Diseases/transmission , Socioeconomic Factors , Surveys and Questionnaires , Vulnerable Populations/psychology , Young Adult
12.
AIDS Behav ; 24(12): 3376-3384, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32405725

ABSTRACT

Transactional sex is associated with incident HIV infection among adolescent girls and young women (AGYW) in sub-Saharan Africa. Evidence on the dimensions of socioeconomic status (SES) which predict transactional sex are mixed and primarily come from cross-sectional studies. This study examined the association between SES and transactional sex in a longitudinal cohort (n = 844) of AGYW ages 15-24 years enrolled in a quasi-experimental study in Lilongwe, Malawi. Prevalence of transactional sex was 22% at baseline, 15% at 6-months and 20% at 12-months. Being divorced or widowed, being food insecure, living in a home without electricity or running water, and having few assets were associated with transactional sex. Higher educational attainment and school enrollment were protective. Having 6-7 socioeconomic risk factors increased odds of transactional sex (AOR = 4.13, 95% CI 2.45, 6.98). Structural interventions which address multiple dimensions of SES may reduce transactional sex and ultimately prevent HIV transmission among AGYW.


Subject(s)
HIV Infections , Adolescent , Cross-Sectional Studies , Female , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Malawi/epidemiology , Sexual Behavior , Socioeconomic Factors , Young Adult
13.
AIDS Behav ; 24(5): 1542-1550, 2020 May.
Article in English | MEDLINE | ID: mdl-31512067

ABSTRACT

Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of many adverse sexual and reproductive health outcomes. Small-group interventions addressing underlying vulnerabilities may influence risky sexual behaviors associated with these adverse outcomes. Girl Power-Malawi assessed whether a facilitator-led, curriculum-driven small-group behavioral intervention impacted risky sexual behaviors among AGYW in Lilongwe, Malawi. Four Health Centers were selected; two were randomly assigned to provide the intervention. Two-hundred fifty AGYW 15-24 years old were enrolled in each clinic (N = 1000 total), followed for 1 year, and interviewed at baseline and endline. At both time points participants reported on two behaviors in the last month (vaginal sex and ≥ 2 sexual partners) and two behaviors in the last year (age-disparate relationships and transactional relationships). In intervention clinics, there were no declines in risk behaviors between baseline and endline. Endline behaviors were not less risky in intervention clinics than control clinics. This intervention did not have a positive effect on four risk behaviors over a 1-year period.


Subject(s)
HIV Infections , Sexual Behavior , Adolescent , Cohort Studies , Female , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Malawi , Risk-Taking , Young Adult
14.
AIDS Care ; 32(2): 170-174, 2020 02.
Article in English | MEDLINE | ID: mdl-31238717

ABSTRACT

Adherence self-efficacy, belief in one's ability to adhere to daily medication, is strongly associated with antiretroviral therapy (ART) adherence and preventing mother-to-child HIV transmission. Couple-based interventions could enhance self-efficacy and adherence. We assessed the relationship between couple HIV testing and counseling (cHTC) and adherence self-efficacy using a 100-point culturally-adapted adherence self-efficacy scale (ASES). Secondarily, we explored the relationship between ASES and ART adherence. Ninety HIV-positive pregnant women at an antenatal clinic in Lilongwe, Malawi were enrolled in an observational cohort study. They were assessed with ASES immediately before and one month after receiving cHTC. Median ASES scores were 100 (IQR 95, 100) before and 100 (IQR 99, 100) after cHTC; there was a significant median difference (p = 0.02) for participants before and after cHTC. This change in ASES scores was associated with the odds of self-reported ART adherence in the full population (OR 1.1, p = 0.01), and there was a trend in the same direction for participants with imperfect baseline ASES scores (OR 1.1, p = 0.2). In our population, adherence self-efficacy and ART adherence were both quite high, and those who had room to improve in self-efficacy may have benefited from cHTC, which in turn could impact ART adherence and ultimately mother-to-child transmission.


Subject(s)
Antiretroviral Therapy, Highly Active/methods , HIV Infections/drug therapy , HIV Infections/prevention & control , Infectious Disease Transmission, Vertical/prevention & control , Medication Adherence/psychology , Pregnancy Complications, Infectious/drug therapy , Pregnant Women/psychology , Self Efficacy , Adult , Cohort Studies , Counseling , Female , HIV Infections/psychology , HIV Infections/transmission , Humans , Malawi/epidemiology , Mass Screening , Pregnancy , Serologic Tests
15.
AIDS Care ; 31(2): 199-206, 2019 02.
Article in English | MEDLINE | ID: mdl-30182730

ABSTRACT

Couples HIV testing and counseling (couple counseling) promotes safer sexual behaviors, increases communication between couples, and decreases HIV transmission. However, the impact of couple counseling on social support, critical for persons living with HIV, has not been examined. Ninety couples with a recently tested HIV-positive pregnant woman (female-positive couples) and 47 couples with a recently tested HIV-negative pregnant woman (female-negative couples) were enrolled in an observational study at an antenatal clinic in Malawi. Each couple member was assessed immediately before and one month after couple counseling for partner, family, and peer social support using the Multidimensional Scale of Perceived Social Support. Before couple counseling, social support was lower among women than men in both female-positive couples (ß = -10.00, p < .01) and female-negative couples (ß = -8.43, p < .01). After couple counseling, social support increased for women in female-positive couples (ß = 4.01, p < .01) and female-negative couples (ß = 4.69, p < .01) but not for men in either type of couple. Couple counseling could be an effective strategy to increase social support for women, including those with recent HIV diagnoses.


Subject(s)
AIDS Serodiagnosis , Counseling , HIV Seropositivity/diagnosis , Pregnant Women , Social Support , Adolescent , Adult , Family , Female , HIV Seronegativity , Humans , Malawi , Male , Peer Group , Pregnancy , Sex Factors , Sexual Partners , Young Adult
16.
J Med Ethics ; 45(6): 388-393, 2019 06.
Article in English | MEDLINE | ID: mdl-31189724

ABSTRACT

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is (1) to analyse a prototypical cluster trial conducted in a low-resource setting (PURE Malawi trial) with the Ottawa Statement; (2) to identify ethical issues in the design or conduct of the trial not captured adequately and (3) to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: (1) streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; (2) the classification of lay health workers who deliver study interventions as health providers or research participants; (3) the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; (4) the timing of gatekeeper engagement, particularly when researchers face funding constraints; (5) providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and (6) defining vulnerable participants needing protection in low-resource settings.


Subject(s)
Developing Countries , Randomized Controlled Trials as Topic/ethics , Anti-HIV Agents/therapeutic use , Ethics Committees, Research/ethics , Ethics Committees, Research/standards , Ethics, Research , HIV Infections/prevention & control , HIV Infections/transmission , Health Resources/ethics , Humans , Infectious Disease Transmission, Vertical/prevention & control , Informed Consent/ethics , Informed Consent/standards , Malawi , Randomized Controlled Trials as Topic/standards , Research Design/standards , Research Subjects , Vulnerable Populations
17.
AIDS Behav ; 22(6): 1775-1786, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29086117

ABSTRACT

We aimed to understand drivers of HIV-infection in pregnant women in Malawi. The study was conducted in antenatal and labor and delivery wards. HIV-infected women and their partners (cases) were frequency matched in a 1:2 ratio based on age and screening location to HIV-uninfected women and their partners (controls) in a prevalent case-control study. Characteristics associated with female HIV infection were assessed using logistic regression modeling. At screening, HIV-infected women were more likely to have partners outside Lilongwe than HIV-uninfected women (24% vs. 0%, p < 0.0001). Case females were more likely to have HIV-infected study partners than control females (75% vs. 4%, p < 0.0001). The odds of female HIV-infection were higher if either couple member reported ≥ 2 lifetime marriages (OR 9.0, CI 2.6-30.9) or ≥ 3 lifetime partners (OR 18.0, CI 3.1-103.6) and lower if either reported past couple HIV testing and counseling (OR 0.1, CI 0.04-0.3). Targeting women with migrating partners, promoting couple HIV testing and counseling, and limiting partners could slow HIV transmission.


Subject(s)
HIV Infections/epidemiology , Pregnant Women/psychology , Sexual Partners/psychology , Adult , Case-Control Studies , Counseling , Female , HIV Infections/diagnosis , Humans , Malawi/epidemiology , Male , Mass Screening , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Young Adult
18.
BMC Infect Dis ; 18(1): 39, 2018 01 15.
Article in English | MEDLINE | ID: mdl-29334932

ABSTRACT

BACKGROUND: Anemia is common among people living with HIV infection and is frequently associated with poor quality of life and poor prognosis. It has been well described in antiretroviral naïve individuals and those on non-nucleoside reverse transcriptase inhibitor-based first line antiretroviral therapy (ART) regimens. However there is limited information on anemia for ART experienced individuals on protease inhibitor-based second line ART regimens in resource limited settings. Our objective was to describe the prevalence and risk factors of anemia in this ART experienced population in Malawi. METHODS: We conducted a cross-sectional study using routine facility data at two HIV clinics in Lilongwe, Malawi. The analysis included individuals receiving protease inhibitor-based second line ART. Clinical and laboratory data were collected at routine clinic visits. We used descriptive statistics, two-sample t-tests and multivariate logistic regression for data analysis. RESULTS: Three hundred seventy-seven records were included in this analysis (37% male, median age 41 years, median CD4 count 415 cells/µL). The prevalence of anemia was 125/377 (33.2%) - mild, moderate and severe anemia was 17.5%, 13.8%, and 1.9% respectively. Female participants had a higher prevalence than male participants (43.6% vs. 15.7%, p < 0.001). In multivariate logistic regression, female sex (adjusted odds ratio (aOR) 5.3; 95% CI 2.9-9.5) and a CD4 count <200 cell/ul (aOR 3.1; 95%CI 1.6-6.0) were associated with increased risk of having anemia while a BMI ≥30 kg/m2 (aOR 0.8; 95% CI 0.6-1.0) and being on ART for more than 10 years (aOR 0.4; 95% CI 0.2-0.9) were associated with reduced risk of anemia. Being on a zidovudine- containing ART regimen was not associated with anemia. CONCLUSION: Anemia is common in people on second line ART in Lilongwe, Malawi. Screening for anemia in this population would be a useful strategy; especially for female patients, those who are underweight and have a low CD4 cell counts.


Subject(s)
Anemia/chemically induced , Anti-HIV Agents/adverse effects , HIV Infections/drug therapy , Reverse Transcriptase Inhibitors/adverse effects , Adult , Anemia/epidemiology , Anti-HIV Agents/therapeutic use , CD4 Lymphocyte Count , Cross-Sectional Studies , Female , Humans , Malawi/epidemiology , Male , Middle Aged , Odds Ratio , Prevalence , Reverse Transcriptase Inhibitors/therapeutic use , Risk Factors , Zidovudine/adverse effects , Zidovudine/therapeutic use
19.
BMC Health Serv Res ; 18(1): 225, 2018 04 02.
Article in English | MEDLINE | ID: mdl-29606125

ABSTRACT

BACKGROUND: Delivery of quality healthcare in resource-limited settings is an important, understudied public health priority. Thirty-day (early) hospital readmission is often avoidable and an important indicator of healthcare quality. METHODS: We investigated the prevalence of all-cause early readmission and its associated factors using age and sex adjusted risk ratios (RR) and 95% confidence intervals (CI). A retrospective review of the medical ward database at Kamuzu Central Hospital in Lilongwe, Malawi was conducted between February and December 2013. RESULTS: There were 3547 patients with an index admission of which 2776 (74.4%) survived and were eligible for readmission. Among these patients: 49.7% were male, mean age was 39.7 years, 36.1% were HIV-positive, 34.6% were HIV-negative, and 29.3% were HIV-unknown. The prevalence of early hospital readmission was 5.5%. Diagnoses associated with 30-day readmission were HIV-positive status (RR = 2.41; 95% CI: 1.64-3.53) and malaria (RR = 0.45; 95% CI: 0.22-0.91). Other factors associated with readmission were multiple diagnoses (excluding HIV) (RR = 1.52; 95% CI: 1.11-2.06), and prolonged length of stay (≥ 16 days) at the index hospitalization (RR = 3.63; 95% CI: 1.72-7.67). CONCLUSION: Targeting HIV-infected inpatients with multiple diagnoses and longer index hospitalizations may prevent early readmission and improve quality of care.


Subject(s)
HIV Infections/epidemiology , Patient Readmission/statistics & numerical data , Adolescent , Adult , Age Distribution , Aged , Female , HIV Infections/therapy , Hospitalization/statistics & numerical data , Hospitals/statistics & numerical data , Humans , Inpatients/statistics & numerical data , Malawi/epidemiology , Male , Middle Aged , Quality of Health Care , Retrospective Studies , Risk Factors , Sex Distribution , Tertiary Care Centers/statistics & numerical data , Young Adult
20.
Trop Med Int Health ; 22(8): 1021-1029, 2017 08.
Article in English | MEDLINE | ID: mdl-28544728

ABSTRACT

OBJECTIVES: Evaluation of a novel index case finding and linkage-to-care programme to identify and link HIV-infected children (1-15 years) and young persons (>15-24 years) to care. METHODS: HIV-infected patients enrolled in HIV services were screened and those who reported untested household members (index cases) were offered home- or facility-based HIV testing and counselling (HTC) of their household by a community health worker (CHW). HIV-infected household members identified were enrolled in a follow-up programme offering home and facility-based follow-up by CHWs. RESULTS: Of the 1567 patients enrolled in HIV services, 1030 (65.7%) were screened and 461 (44.8%) identified as index cases; 93.5% consented to HIV testing of their households and of those, 279 (64.7%) reported an untested child or young person. CHWs tested 711 children and young persons, newly diagnosed 28 HIV-infected persons (yield 4.0%; 95% CI: 2.7-5.6), and identified an additional two HIV-infected persons not enrolled in care. Of the 30 HIV-infected persons identified, 23 (76.6%) were linked to HIV services; 18 of the 20 eligible for ART (90.0%) were initiated. Median time (IQR) from identification to enrolment into HIV services was 4 days (1-8) and from identification to ART start was 6 days (1-8). CONCLUSIONS: Almost half of HIV-infected patients enrolled in treatment services had untested household members, many of whom were children and young persons. Index case finding, coupled with home-based testing and tracked follow-up, is acceptable, feasible and facilitates the identification and timely linkage to care of HIV-infected children and young persons.


Subject(s)
Community Health Services , Family Characteristics , HIV Infections/drug therapy , Mass Screening , Adolescent , Adult , Anti-HIV Agents/therapeutic use , Child , Child, Preschool , Community Health Workers , Counseling , HIV Infections/diagnosis , Humans , Malawi , Young Adult
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