Home Blood Pressure Management Intervention in Low- to Middle-Income Countries: Protocol for a Mixed Methods Study.

BACKGROUND: Control of hypertension in low- and middle-income countries (LMICs) is poor, often less than 10%. A strong body of evidence demonstrates that home blood pressure management lowers blood pressure, and recent guidelines from the National Institute for Clinical Health and Excellence recommends home blood pressure monitoring. However, the preponderance of data on the benefits of home blood pressure management comes from studies in high-income countries. OBJECTIVE: The objective of the study is to examine whether an intervention of home blood pressure management is feasible in LMICs. Home blood pressure management is defined as self-monitoring of blood pressure and self-titration of antihypertensive medications. We will identify barriers and facilitators of home blood pressure management and explore unique contextual factors in LMICs that influence implementation of home blood pressure management. METHODS: Participants will be recruited from 6 sites from 2015 to 2018. Patients and health care workers will be included. We will use mixed methods including focus groups, interviews, and standardized checklists. When possible, we will adapt materials from prior successful studies so that they are culturally and contextually appropriate. RESULTS: This ongoing study is funded by the World Heart Federation. The information that is obtained will be used to develop a randomized clinical trial of home blood pressure management in LMICs. CONCLUSIONS: The data generated from this qualitative study will provide much needed information from patients and health care workers about barriers and facilitators of home blood pressure management and unique contextual factors that might influence implementation of home blood pressure management in LMICs

HIV risk perception and sexual behavior among HIV-uninfected men and transgender women who have sex with men in sub-Saharan Africa: Findings from the HPTN 075 qualitative sub-study.

There remains a limited understanding of how men who have sex with men (MSM) and transgender women (TGW) in sub-Saharan Africa (SSA) perceive their risk for HIV and how risk influences behavior during sexual interactions. We performed thematic analysis on in-depth interviews from the qualitative sub-study of HPTN 075 in Kenya, Malawi, and South Africa. Using the Integrated Behavioral Model (IBM) constructs, we found that most MSM and TGW perceived themselves to be at risk for HIV, leading them to regularly engage in safer sexual behaviors. Notably, even though these MSM and TGW perceived themselves to be at risk for HIV, some of them reported engaging in transactional sex, sex under the influence of alcohol, and intentional non-use of condoms. This indicates that HIV risk perception was not always associated with safer sexual behaviors or a reduction in risk behaviors. Attitudes (negative attitudes toward condom use), perceived norms (social pressures), and environment constraints (contextual barriers) were related to MSM and TGW not engaging in safe sexual behavior. Hearing the perspectives of MSM and TGW on their sexual behavior continues to be important for the development and implementation of effective prevention policies and interventions. Eliminating structural barriers such as stigma, discrimination, and criminalization of same-sex sexuality is a crucial prerequisite for the success of interventions to promote sexual health among MSM and TGW in SSA

Progesterone and prolactin levels in pregnant women living with HIV who delivered preterm and low birthweight infants: A nested case-control study

Background Antiretroviral therapy (ART) is associated with high rates of adverse birth outcomes, including preterm birth and low birthweight. Studies suggest that progesterone and prolactin may play important intermediary roles. Methods We analyzed data from the Antenatal Component of the PROMISE trial, a multi-center study of pregnant women taking antiretroviral regimens (lopinavir/ritonavir-containing ART or zidovudine alone) to prevent mother-to-child HIV transmission. In a nested case-control study, we compared data from women who gave birth to preterm (<37 weeks gestation) and/or low birthweight (<2500 g) infants to matched individuals who did not. We measured serum progesterone and prolactin at 24–34 weeks gestation. We used conditional logistic regression to describe relationships between hormone levels, birth outcomes, and antiretroviral regimens. Results 299 women and their newborns were included (146 cases, 153 controls). When compared to women receiving zidovudine alone, those on ART had higher odds of progesterone levels under the 10th percentile (adjusted odds ratio [AOR]:2.34, 95%CI:1.41–3.89) and 25th percentile (AOR:2.07, 95%CI:1.46–2.94). However, higher levels of progesterone—rather than lower levels—were associated with our composite case outcome at the 10th percentile (AOR:1.88, 95%CI:0.77–4.59) and 25th percentile (AOR:1.96, 95%CI:1.06–3.61). Associations were not observed between prolactin, antiretroviral regimen, and birth outcomes. Conclusion We observed lower progesterone levels among women allocated to ART regimens; however, higher progesterone levels were associated with preterm birth and/or low birthweight. While features of the study design may have contributed to these findings, they nevertheless highlight the potentially complex mechanisms underpinning adverse birth outcomes and HIV

Factors Associated with HIV Infection in Married or Cohabitating Couples in Kenya: Results from a Nationally Representative Study

BACKGROUND: In order to inform prevention programming, we analyzed HIV discordance and concordance within couples in the Kenya AIDS Indicator Survey (KAIS) 2007. METHODS: KAIS was a nationally representative population-based sero-survey that examined demographic and behavioral indicators and serologic testing for HIV, HSV-2, syphilis, and CD4 cell counts in 15,853 consenting adults aged 15-64 years. We analyzed interview and blood testing data at the sexual partnership level from married or cohabitating couples. Multivariable regression models were used to identify factors independently associated with HIV discordant and concordant status. RESULTS: Of 3256 couples identified in the survey, 2748 (84.4%) had interview and blood testing data. Overall, 3.8% of couples were concordantly infected with HIV, and in 5.8% one partner was infected, translating to 338,000 discordant couples in Kenya. In 83.6% of HIV-infected Kenyans living in married or cohabitating couples neither partner knew their HIV status. Factors independently associated with HIV-discordance included young age in women (AOR 1.5, 95% CI: 1.2-1.8; p<0.0001), increasing number of lifetime sexual partners in women (AOR 1.5, 95% CI: 1.3-1.8; p<0.0001), HSV-2 infection in either or both partners (AOR 4.1, 95% CI: 2.3-7.2; p<0.0001), and lack of male circumcision (AOR 1.6, 95% CI: 1.0-2.5; p = 0.032). Independent factors for HIV-concordance included HSV-2 infection in both partners (AOR 6.5, 95% CI: 2.3-18.7; p = 0.001) and lack of male circumcision (AOR 1.8, 95% CI: 1.0-3.3; p = 0.043). CONCLUSIONS: Couple prevention interventions should begin early in relationships and include mutual knowledge of HIV status, reduction of outside sexual partners, and promotion of male circumcision among HIV-uninfected men. Mechanisms for effective prevention or suppression of HSV-2 infection are also needed

Near-universal same-day linkage to ART care among newly diagnosed adults living with HIV: A cross-sectional study from primary health facilities, in urban Malawi.

Malawi HIV treatment guidelines recommend same-day antiretroviral therapy (ART) initiation. Overall 97.9% of Malawians living with HIV (PLHIV) are on ART, same-day ART initiation prevalence and factors that facilitate it have not been fully described. We assessed same-day ART initiation and described individual, health system and health facility infrastructural factors at health facilities supported by expert clients (EC). ECs are lay PLHIV who support other PLHIV. The study was conducted in urban and semi-urban primary health facilities, in Blantyre, Malawi. It was a cross-sectional, descriptive survey of PLHIV and health facility leaders. Eligibility criteria included age ≥ 18 years, new diagnosis of HIV, received counselling from ECs, and offered same-day ART. The study was conducted from December 2018 to June 2021, and 321 study participants enrolled. Mean age (standard deviation) was 33 years (10) with 59% females. In total, 315 (98.1%) initiated same-day ART. Four participants did not because of mental unpreparedness, one wanted to try herbal medicine and one was concerned about stigma related to taking ART. Participants reported health facility accessibility (99%, 318/321), privacy (91%, 292/321) and quality of counselling by EC as excellent (40%, 128/321). Same-day ART was nearly universal. Participants' satisfaction with health services delivery, the presence of EC, and infrastructural characteristics such as adequate privacy were cited as reasons favoring same-day linkage to ART. The most cited reason for not starting same-day ART was mental unpreparedness

Use of effective family planning methods and frequency of sex among HIV-infected and HIV-uninfected African women

Abstract Background Frequency of sex, contraceptive use and HIV infection are key determinants of fertility. Use of an effective family planning (EFP) method (injectable, oral, intra-uterine contraceptive device (IUCD), or Norplant) potentially eliminates women’s concerns of unintended pregnancy. We report the association between EFP and frequency of sex among HIV-infected and HIV-uninfected non-pregnant African women. Methods Prospective fertility intentions study nested within a phase 3 randomized double-masked placebo-controlled trial (2003-2005) to treat genital tract infections in HIV-infected and HIV-uninfected non-pregnant women. Enrollment of study participants was stratified by HIV infection status. Data on demographics, family planning and sexual history were obtained at baseline and at 3, 6, 9 and 12 months. Chi square and Wilcoxon Rank-Sum tests were used to compare categorical and continuous variables, respectively. Generalized Estimating Equations method was used to estimate relative risk (RR) of frequent sex (≥ 2 acts/week) among users of different EFP methods (injectable, oral, implant or intra-uterine contraceptive device). Results After adjusting for age, current health status, and fertility intentions, EFP use was significantly associated with frequent sex among HIV-infected women (RR 1.32; 95% Confidence Interval [CI] 1.14-1.52); this association was not statistically significant among HIV-uninfected women (RR 1.10; 95% CI 0.96-1.24). Fertility intentions among HIV-infected, and education among HIV-uninfected womenwere independent predictors of sex frequency. Conclusion These data suggest that the association between EFP use and frequency of sex among women varies by HIV infection status. Service-delivery of diverse EFP methods should be integrated within HIV counseling, testing and treatment facilities. Trial registration Registration number NCT00140764 under the clinicaltrials.gov, first Posted: September 1, 2005, last Update Posted: August 10, 2011

A Malawi guideline for research study participant remuneration [version 2; referees: 2 approved]

Background: Research participant remuneration has been variable and inconsistent world-wide for many years owing to uncertainty regarding best practice and a lack of written guidelines for investigators and research ethics committees.  Recent recommendations are that researchers and regulators should develop regionally appropriate written guidelines to define reasonable remuneration based on expense reimbursement, compensation for time and burden associated with participation.   Incentives to motivate participation are acceptable in specific circumstances. Methods: We wished to develop regionally informed, precise and applicable guidelines in Malawi that might also be generally useful for African researchers and review committees.  We therefore reviewed the current literature and developed widely applicable and specific remuneration tables using acceptable and evidence-based payment rationales. Results: There were good international guidelines and limited published regional guidelines.  There were published examples of best practice and sufficient material to suggest a structured remuneration table.  The rationale and method for the table were discussed at an inter-disciplinary workshop resulting in a reimbursement and compensation model with fixed rates.  Payment is recommended pro rata and equally across a study. Conclusions: Transparent, fair remuneration of research participants is recommended by researchers and regulators in Malawi.  The means to achieve this are now presented in the Malawi research participant remuneration table

Prevalence of HIV, sexually transmitted infections, and risk behaviors among female sex workers in Nairobi, Kenya: Results of a respondent driven sampling study

We conducted a respondent driven sampling survey to estimate HIV prevalence and risk behavior among female sex workers (FSWs) in Nairobi, Kenya. Women aged 18 years and older who reported selling sex to a man at least once in the past 3 months were eligible to participate. Consenting FSWs completed a behavioral questionnaire and were tested for HIV and sexually transmitted infections (STIs). Adjusted population-based prevalence and 95 % confidence intervals (CI) were estimated using RDS analysis tool. Factors significantly associated with HIV infection were assessed using log-binomial regression analysis. A total of 596 eligible participants were included in the analysis. Overall HIV prevalence was 29.5 % (95 % CI 24.7–34.9). Median age was 30 years (IQR 25–38 years); median duration of sex work was 12 years (IQR 8–17 years). The most frequent client-seeking venues were bars (76.6 %) and roadsides (29.3 %). The median number of clients per week was seven (IQR 4–18 clients). HIV testing was high with 86.6 % reported ever been tested for HIV and, of these, 63.1 % testing within the past 12 months. Of all women, 59.7 % perceived themselves at \u27great risk\u27 for HIV infection. Of HIV-positive women, 51.0 % were aware of their infection. In multivariable analysis, increasing age, inconsistent condom use with paying clients, and use of a male condom as a method of contraception were independently associated with unrecognized HIV infection. Prevalence among STIs was low, ranging from 0.9 % for syphilis, 1.1 % for gonorrhea, and 3.1 % for Chlamydia. The data suggest high prevalence of HIV among FSWs in Nairobi. Targeted and routine HIV and STI combination prevention strategies need to be scaled up or established to meet the needs of this population