Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry.

BACKGROUND: Adolescent girls may experience poor psychological well-being, such as social isolation, shame, anxiety, hopelessness, and despair linked to food insecurity. OBJECTIVES: This study aimed to investigate the experiences with and perceived effects of a household-level income-generating agricultural intervention on the psychological well-being of adolescent girls in human immunodeficiency virus (HIV)-affected households in southwestern Kenya. METHODS: We conducted 62 in-depth interviews with HIV-affected adolescent girls and caregiver dyads in Adolescent Shamba Maisha (NCT03741634), a sub-study of adolescent girls and caregivers with a household member participating in Shamba Maisha (NCT01548599), a multisectoral agricultural and finance intervention trial aimed to improve food security and HIV health indicators. Participants were purposively sampled to ensure diversity in terms of age and location. Data were audiotaped, transcribed, translated, and uploaded into Dedoose (Sociocultural Research Consultants, LLC) software for management. Data were analyzed thematically based on reports from Dedoose. RESULTS: We found evidence that a household-level structural intervention aimed at increasing food and financial security among persons living with HIV can contribute to better psychological well-being among adolescent girls residing in these households. The intervention also affected: 1) reduction of social isolation, 2) reduction of shame and stigma, 3) increased attendance and concentration in school, 4) improved caregiver mental health, and 5) reduced parental aggression and improved household communication. These associations were reported more commonly among those in the intervention arm than the control arm. CONCLUSIONS: This study extends existing research by demonstrating how multisectoral structural interventions delivered at a household level can improve the psychological well-being of adolescents. We recommend that future research test livelihood interventions designed specifically for adolescent girls that integrate food-security interventions with other elements to address the social and psychological consequences of food insecurity holistically. This trial was registered at clinicaltrials.gov as NCT03741634.

Effect of a patient-centered hypertension delivery strategy on all-cause mortality: Secondary analysis of SEARCH, a community-randomized trial in rural Kenya and Uganda.

BACKGROUND: Hypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda. METHODS AND FINDINGS: This is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure <140/90 mm Hg on 3 repeated measures). Between-arm comparisons used cluster-level targeted maximum likelihood estimation. Among 86,078 adults screened at study baseline (June 2013 to July 2014), 10,928 (13%) had uncontrolled hypertension. Median age was 53 years (25th to 75th percentile 40 to 66); 6,058 (55%) were female; 677 (6%) were HIV infected; and 477 (4%) had diabetes mellitus. Overall, 174 participants (3.2%) in the intervention group and 225 participants (4.1%) in the control group died during 3 years of follow-up (adjusted relative risk (aRR) 0.79, 95% confidence interval (CI) 0.64 to 0.97, p = 0.028). Among those with baseline grade 3 hypertension (≥180/110 mm Hg), 22 (4.9%) in the intervention group and 42 (7.9%) in the control group died during 3 years of follow-up (aRR 0.62, 95% CI 0.39 to 0.97, p = 0.038). Estimated population-level hypertension control at year 3 was 53% in intervention and 44% in control communities (aRR 1.22, 95% CI 1.12 to 1.33, p < 0.001). Study limitations include inability to identify specific causes of death and control conditions that exceeded current standard hypertension care. CONCLUSIONS: In this cluster randomized comparison where both arms received population-level hypertension screening, implementation of a patient-centered hypertension care model was associated with a 21% reduction in all-cause mortality and a 22% improvement in hypertension control compared to standard care among adults with baseline uncontrolled hypertension. Patient-centered chronic care programs for HIV can be leveraged to reduce the overall burden of cardiovascular mortality in SSA. TRIAL REGISTRATION: ClinicalTrials.gov NCT01864603.

Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

BACKGROUND: Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART. METHODS/DESIGN: This study is a cluster randomized, 2 × 2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care. DISCUSSION: This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02491177 . Registered on 11 March 2015.

Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

OBJECTIVES: To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. DESIGN: Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. SETTING: Eighteen health facilities in Kenya. SUBJECTS: Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. INTERVENTION: "One-stop shop" approach to integrating FP and HIV services. MAIN OUTCOME MEASURES: Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. RESULTS: Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19-1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87). CONCLUSIONS: Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001507.

Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda.

BACKGROUND: Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings. METHODS AND FINDINGS: Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP. CONCLUSIONS: Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Does Integrating Family Planning into HIV Services Improve Gender Equitable Attitudes? Results from a Cluster Randomized Trial in Nyanza, Kenya.

This study investigated whether integrating family planning (FP) services into HIV care was associated with gender equitable attitudes among HIV-positive adults in western Kenya. Surveys were conducted with 480 women and 480 men obtaining HIV services from 18 clinics 1 year after the sites were randomized to integrated FP/HIV services (N = 12) or standard referral for FP (N = 6). We used multivariable regression, with generalized estimating equations to account for clustering, to assess whether gender attitudes (range 0-12) were associated with integrated care and with contraceptive use. Men at intervention sites had stronger gender equitable attitudes than those at control sites (adjusted mean difference in scores = 0.89, 95 % CI 0.03-1.74). Among women, attitudes did not differ by study arm. Gender equitable attitudes were not associated with contraceptive use among men (AOR = 1.06, 95 % CI 0.93-1.21) or women (AOR = 1.03, 95 % CI 0.94-1.13). Further work is needed to understand how integrating FP into HIV care affects gender relations, and how improved gender equity among men might be leveraged to improve contraceptive use and other reproductive health outcomes.

Integrating family planning and HIV services in western Kenya: the impact on HIV-infected patients' knowledge of family planning and male attitudes toward family planning.

Little information exists on the impact of integrating family planning (FP) services into HIV care and treatment on patients' familiarity with and attitudes toward FP. We conducted a cluster-randomized trial in 18 public HIV clinics with 12 randomized to integrated FP and HIV services and 6 to the standard referral-based system where patients are referred to an FP clinic. Serial cross-sectional surveys were done before (n = 488 women, 486 men) and after (n = 479 women, 481 men) the intervention to compare changes in familiarity with FP methods and attitudes toward FP between integrated and nonintegrated (NI) sites. We created an FP familiarity score based on the number of more effective FP methods patients could identify (score range: 0-6). Generalized estimating equations were used to control for clustering within sites. An increase in mean familiarity score between baseline (mean = 5.16) and post-intervention (mean = 5.46) occurred with an overall mean change of 0.26 (95% confidence intervals [CI] = 0.09, 0.45; p = 0.003) across all sites. At end line, there was no difference in increase of mean FP familiarity scores at intervention versus control sites (mean = 5.41 vs. 5.49, p = 0.94). We observed a relative decrease in the proportion of males agreeing that FP was "women's business" at integrated sites (baseline 42% to end line 30%; reduction of 12%) compared to males at NI sites (baseline 35% to end line 42%; increase of 7%; adjusted odds ration [aOR] = 0.43; 95% CI = 0.22, 0.85). Following FP-HIV integration, familiarity with FP methods increased but did not differ by study arm. Integration was associated with a decrease in negative attitudes toward FP among men.

Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial.

OBJECTIVE: To determine whether integrating family planning services into HIV care is associated with increased use of more effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral contraceptives). DESIGN: Cluster-randomized trial. SETTING: Eighteen public HIV clinics in Nyanza Province, Kenya. PARTICIPANTS: Women aged 18-45 years receiving care at participating HIV clinics; 5682 clinical encounters from baseline period (December 2009-February 2010) and 12,531 encounters from end-line period (July 2011-September 2011, 1 year after site training). INTERVENTION: Twelve sites were randomized to integrate family planning services into the HIV clinic, whereas six clinics were controls where clients desiring contraception were referred to family planning clinics at the same facility. MAIN OUTCOME MEASURES: Increase in use of more effective contraceptive methods between baseline and end-line periods. Pregnancy rates during the follow-up year (October 2010-September 2011) were also compared. RESULTS: Women seen at integrated sites were significantly more likely to use more effective contraceptive methods at the end of the study [increased from 16.7 to 36.6% at integrated sites, compared to increase from 21.1 to 29.8% at controls; odds ratio (OR) 1.81, 95% confidence interval (CI) 1.24-2.63]. Condom use decreased non-significantly at intervention sites compared to controls (OR 0.64, 95% CI 0.35-1.19). No difference was observed in incident pregnancy in the first year after integration comparing intervention to control sites (incidence rate ratio 0.90; 95% CI 0.68-1.20). CONCLUSIONS: Integration of family planning services into HIV care clinics increased use of more effective contraceptive methods with a non-significant reduction in condom use. Although no significant reduction in pregnancy incidence was observed during the study, 1 year may be too short a period of observation for this outcome.

Cost, cost-efficiency and cost-effectiveness of integrated family planning and HIV services.

OBJECTIVE: To evaluate costs, cost-efficiency and cost-effectiveness of integration of family planning into HIV services. INTERVENTION: Integration of family planning services into HIV care and treatment clinics. DESIGN: A cluster-randomized trial. SETTING: Twelve health facilities in Nyanza, Kenya were randomized to integrate family planning into HIV care and treatment; six health facilities were randomized to (nonintegrated) standard-of-care with separately delivered family planning and HIV services. MAIN OUTCOME MEASURES: We assessed costs, cost-efficiency (cost per additional use of more effective family planning), and cost-effectiveness (cost per pregnancy averted) associated with the first year of integration of family planning into HIV care. More effective family planning methods included oral and injectable contraceptives, subdermal implants, intrauterine device, and female and male sterilization. PATIENTS AND PARTICIPANTS: We collected cost data through interviews with study staff and review of financial records to determine costs of service integration. RESULTS: Integration of services was associated with an average marginal cost of $841 per site and $48 per female patient. Average overall and marginal costs of integration were associated with personnel costs [initial ($1003 vs. $872) and refresher ($498 vs. $330) training, mentoring ($1175 vs. $902) and supervision ($1694 vs. $1636)], with fewer resources required for other fixed ($18 vs. $0) and recurring expenses ($471 vs. $287). Integration was associated with a marginal cost of $65 for each additional use of more effective family planning and $1368 for each pregnancy averted. CONCLUSION: Integration of family planning and HIV services is feasible, inexpensive to implement, and cost-efficient in the Kenyan setting, and thus supports current Kenyan integration policy.

Does integrating family planning into HIV care and treatment impact intention to use contraception? Patient perspectives from HIV-infected individuals in Nyanza Province, Kenya.

OBJECTIVE: To evaluate whether HIV-infected women and men in HIV care and not using highly effective methods of contraception thought they would be more likely to use contraception if it were available at the HIV clinic. METHODS: A face-to-face survey assessing family-planning knowledge, attitudes, and practices was conducted among 976 HIV-infected women and men at 18 public-sector HIV clinics in Nyanza, Kenya. Data were analyzed using logistic regression and generalized estimating equations. RESULTS: The majority of women (73%) and men (71%) thought that they or their partner would be more likely to use family planning if it were offered at the HIV clinic. In multivariable analysis, women who reported making family-planning decisions with their partner (adjusted odds ratio [aOR] 3.22; 95% confidence interval [CI], 1.53-6.80) and women aged 18-25 years who were not currently using family planning (aOR 4.76; 95% CI, 2.28-9.95) were more likely to think they would use contraception if integrated services were available. Women who perceived themselves to be infertile (aOR 0.07; 95% CI, 0.02-0.31) and had access to a cell phone (aOR 0.40; 95% CI, 0.25-0.63) were less likely to think that integrated services would change their contraceptive use. Men who were not taking antiretroviral medications (aOR 3.30; 95% CI, 1.49-7.29) were more likely, and men who were unsure of their partner's desired number of children (aOR 0.36; 95% CI, 0.17-0.76), were not currently using family planning (aOR 0.40; 95% CI, 0.22-0.73), and were living in a peri-urban setting (aOR 0.46; 95% CI, 0.21-0.99) were less likely to think their partner would use contraception if available at the HIV clinic. CONCLUSIONS: Integrating family planning into HIV care would probably have a broad impact on the majority of women and men accessing HIV care and treatment. Integrated services would offer the opportunity to involve men more actively in the contraceptive decision-making process, potentially addressing 2 barriers to family planning: access to contraception and partner uncertainty or opposition.

How perceptions of HIV-related stigma affect decision-making regarding childbirth in rural Kenya.

INTRODUCTION: HIV prevalence among pregnant women in Kenya is high. Furthermore, there is a high risk of maternal mortality, as many women do not give birth with a skilled healthcare provider. Previous research suggests that fears of HIV testing and unwanted disclosure of HIV status may be important barriers to utilizing maternity services. We explored relationships between women's perceptions of HIV-related stigma and their attitudes and intentions regarding facility-based childbirth. METHODS: 1,777 pregnant women were interviewed at their first antenatal care visit. We included socio-demographic characteristics, stigma scales, HIV knowledge measures, and an 11-item scale measuring health facility birth attitudes (HFBA). HFBA includes items on cost, transport, comfort, interpersonal relations, and services during delivery at a health facility versus at home. A higher mean HFBA score indicates a more positive attitude towards facility-based childbirth. The mean HFBA score was dichotomized at the median and analyses were conducted with this dichotomized HFBA score using mixed effects logit models. RESULTS: Women who anticipated HIV-related stigma from their male partner had lower adjusted odds of having positive attitudes about giving birth at the health facility (adjusted OR = .63, 95% CI 0.50-0.78) and less positive attitudes about health facility birth were strongly related to women's intention to give birth outside a health facility (adjusted OR = 5.56, 95% CI 2.69-11.51). CONCLUSIONS: In this sample of pregnant women in rural Kenya, those who anticipated HIV-related stigma were less likely to have positive attitudes towards facility-based childbirth. Furthermore, negative attitudes about facility-based childbirth were associated with the intention to deliver outside a health facility. Thus, HIV-related stigma reduction efforts might result in more positive attitudes towards facility-based childbirth, and thereby lead to an increased level of skilled birth attendance, and reductions in maternal and infant mortality.

Fertility intentions and interest in integrated family planning services among women living with HIV in Nyanza Province, Kenya: a qualitative study.

Despite increasing efforts to address the reproductive health needs of people living with HIV, a high unmet need for contraception exists among HIV+ women in sub-Saharan Africa. This study explores the fertility intentions and family planning (FP) preferences of Kenyan women accessing HIV treatment. We conducted 30 semistructured interviews and qualitatively analyzed the data with a grounded theory approach. Fears of premature death, financial hardship, and perinatal HIV transmission emerged as reasons for participants' desire to delay/cease childbearing. Participants strongly identified FP needs, yet two-thirds were using male condoms alone or no modern method of contraception. Women preferred the HIV clinic as the site of FP access for reasons of convenience, provider expertise, and a sense of belonging, though some had privacy concerns. Our findings support the acceptability of integrated FP and HIV services. Efforts to empower women living with HIV to prevent unintended pregnancies must expand access to contraceptive methods, provide confidential services, and take into account women's varied reproductive intentions.

Patient satisfaction with integrated HIV and antenatal care services in rural Kenya.

A cluster randomized controlled trial was initiated in Kenya to determine if full integration (FI) of HIV care, including HAART, into antenatal care (ANC) clinics improves health outcomes among HIV-infected women and exposed infants, compared to a non-integrated (NI) model. This article examines ANC clients' satisfaction with and preferences regarding HIV-integrated services. In this cross-sectional study, pregnant women attending five FI clinics (n=185) and four NI clinics (n=141) completed an interviewer-administered questionnaire following an ANC visit. By self-report, 55 women (17%) were HIV(+), 230 (71%) were HIV(-), and 40 (12%) did not know their HIV status. Among HIV-infected women, 79% attending FI clinics were very satisfied with their clinic visit compared to 54% of women attending NI clinics (P=0.044); no such difference was found among HIV-uninfected women. In multivariate analysis, overall satisfaction was also independently associated with satisfaction with administrative staff, satisfaction with health care providers, positive evaluation of wait time, and having encountered a receptionist. Full integration of HIV care into antenatal clinics can significantly increase overall satisfaction with care for HIV-infected women, with no significant decrease in satisfaction for HIV-uninfected women served in the same clinics.

Acceptability and feasibility of integration of HIV care services into antenatal clinics in rural Kenya: a qualitative provider interview study.

The aim of this study was to explore the perspectives of healthcare providers on the advantages and disadvantages of integrating HIV care services, including highly active antiretroviral therapy (HAART), into antenatal care (ANC) clinics in rural Kenya. We conducted a qualitative study using in-depth interviews and thematic analysis; 36 healthcare providers from six health centres in Nyanza Province, Kenya participated. Effects on service providers included increased workload due to the incorporation of specialised HIV services into ANC clinics. Providers observed that integration results in decreased patient time spent at the health facility, increased efficiency and closer provider-patient relationships; all leading to increased patient satisfaction. Providers also said that women would be more likely to receive HAART and adhere to their treatment as a result of improved confidentiality and decreased stigma. However, a minority of providers noted that integration could result in longer appointment times for HIV-positive women at ANC clinics leading to inadvertent disclosure. Integration could lead to strengthened ANC, postpartum care, prevention of mother-to-child transmission and HIV care for women and their families. However, integration efforts need to take into account potential negative effects on ANC provider workload, disclosure and the quality of care.

Medical pluralism on Mfangano Island: use of medicinal plants among persons living with HIV/AIDS in Suba District, Kenya.

ETHNOPHARMACOLOGICAL RELEVANCE: Given the increasing coverage of antiretroviral therapy (ART) for HIV/AIDS treatment as well as the high utilization of herbal medicine, many persons living with HIV/AIDS in sub-Saharan Africa are thought to practice medical pluralism, or the adoption of more than one medical system for their care and treatment. Using a cross-sectional study we sought to document and identify the herbal medicines used by persons living with HIV/AIDS on Mfangano Island, Suba District, Nyanza Province, Kenya. MATERIALS AND METHODS: We interviewed herbalists and knowledgeable mothers to obtain information regarding medicinal plants, particularly for HIV/AIDS-related symptoms, HIV/AIDS, and chira (an illness concept with similarities to HIV/AIDS regarding sexual transmission and wasting symptoms). Using systematic sampling, 67 persons living with HIV/AIDS (49 of whom were receiving ART) were selected from an Mfangano Island health clinic and participated in semi-structured interviews. RESULTS: Interviews with herbalists and mothers identified 40 plant species in 37 genera and 29 families that a person with HIV/AIDS or chira could use for herbal remedies. Overall, 70.1% of persons living with HIV/AIDS had used medicinal plants after HIV diagnosis, most commonly to treat symptoms related to HIV/AIDS. In addition to common vegetables and fruits that can serve medicinal purposes, Azadirachta indica A. Juss. (Meliaceae), Carissa edulis (Forssk.) Vahl (Apocynaceae), and Ximenia americana L. (Olacaceae) were the most frequently cited medicinal plants used by persons living with HIV/AIDS. CONCLUSIONS: Collaboration and communication between biomedical clinicians and herbalists should be encouraged given high rates of concomitant ART-herb usage. Pharmacological, toxicological, and ART-herb interaction studies based on the plants identified in this study and their constituent ingredients should be considered.