Posts classified under: Women

HPTN-083

Abstract: Cabotegravir LA (CAB LA) is a long-acting injectable integrase inhibitor, also known as GSK 1265744 LA or 744 LA. This is a Phase 2b/3 study designed to establish the efficacy of CAB LA for pre-exposure prophylaxis (PrEP) in HIV-uninfected men who have sex with men (MSM) and in transgender women (TGW). Small single-dose and multiple-dose studies and Phase 2a safety/tolerability studies have been performed for CAB LA. This PrEP efficacy study is the next developmental investigation of CAB LA in healthy, HIV-uninfected MSM and TGW. CAB LA is the first antiretroviral (ARV) drug being studied as an intervention for HIV prevention prior to regulatory approval of the drug for HIV treatment. A parallel development program for use of cabotegravir (oral and injectable) for treatment of HIV-infected individuals is currently in Phase 2b studies with a salutary safety and efficacy profile to date.

To enroll in HPTN-083, click here for more information.

Project Number: 5um1ai068619-11

HPTN-077

Abstract: To evaluate the safety, tolerability, pharmacokinetics and acceptability of the injectable agent, GSK1265744 long-acting injectable (744LA), in healthy, HIV-uninfected men and women. It is a multi-site, double-blind, two-arm, randomized, placebo-controlled trial of the safety, tolerability, and acceptability of 744LA. HPTN-077 will study HIV-uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65. of approximately 176 men and women, randomized 3:1, with 132 in the active drug arm, and 44 in the placebo arm. It is anticipated that approximately 60% of the enrolled participants will be women. Participants will be randomized to receive daily oral GSK1265744 (30 mg tablets) or daily oral placebo for 4 weeks, followed by a one-week washout, to assess safety and tolerability before they receive injections. After safety and tolerability assessments from the oral phase have been completed (if no concerns are identified), participants will enter the injection phase of the study and will receive two intra-muscular (IM) gluteal injections of 744LA (800 mg, administered as two 400 mg injections) or placebo (matching vehicle control) at three study visits performed at 12-week intervals.

Project Number: 5UM1AI068619-11

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

Abstract: Daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) as part of a combination prevention package has been shown to be effective for HIV prevention in randomized control trials of MSM and heterosexual men and women at risk for HIV infection; however, some studies in African women have shown lack of efficacy that is believed to be in large part due to inadequate PrEP adherence. In addition, pharmacokinetic studies in women suggest that near-perfect adherence for TDF/FTC oral dosing may be more critical for protection against vaginal compared to rectal exposures. Taken together, these results imply that women may require substantially greater levels of adherence to oral TDF/FTC to effectively decrease HIV acquisition. Therefore, interventions to optimize adherence are particularly vital to maximizing the protective efficacy of PrEP for women. Although current FDA approval and CDC clinical guidelines for oral TDF/FTC as PrEP include at-risk women as candidates for use, limited clinical data exists on the use of PrEP in US women. Further research is needed to advance effective implementation, particularly taking into account the known challenges to achieving and maintaining high levels of adherence for women. In this demonstration project, we will evaluate adherence to, and acceptability of once-daily oral TDF/FTC as PrEP among HIV-uninfected women in Southern California who are at increased risk of HIV acquisition. Los Angeles and San Diego represent two of the top three counties in California of number of reported HIV/AIDS cases. In combination, they total over half of the number of HIV cases in the state supporting the need for ongoing prevention efforts in all at-risk populations (1). Working in tandem, the LAC PATH and CCTG partnership provides a unique opportunity to further collaborative research that has been fostered within the CHRP funding structure, capitalizing on the strengths of existing individual projects in MSM and transgender women.

Electronic HIV Prevention in Los Angeles

Electronic, Technology, HIV Messaging

This pilot study conducted and analyzed responses from eight focus groups (6-8 people each) with staff and clients from community-based organizations (CBOs) which provide HIV prevention services to women.

The specific aims of this project are:

  1. To gather initial information on which electronic communication channels (e.g., the Internet, personal digital assistants (PDAs), or cell phones, or some combination) minority women would prefer to receive electronic HIV (e-HIV) prevention messaging.
  2. To develop and solicit responses to sample brief e-HIV prevention messaging.

Teens and Adults Learning to Communicate (TALC: LA)

Project TALC was funded by the National Institute of Mental Health (NIMH) to evaluate the efficacy of a family-based intervention over time and to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era. Mothers living with HIV (MLH; n = 339) and their school-age children (n = 259) were randomly assigned to receive a behavioral intervention or standard care as the control condition. MLH and their children were compared to non-HIV-affected families recruited at neighborhood shopping markets.

Targeted Risk Group: 

HIV-positive mothers and their adolescent children

Published Journal Articles:

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Links to Interventions, Training Manuals, etc. : 

 Phase 1 – Taking Care Of Myself

Parents’ Curriculum

Phase 2 – Illness

Parents’ Curriculum

  1. TALC LA- Parents Phase 2, Sess 1: What Are My Children's Needs?
  2. TALC LA- Parents Phase 2, Sess 2: Who Will Take Care of My Children?
  3. TALC LA- Parents Phase 2, Sess 3: What Kind of Arrangements Can I Make?
  4. TALC LA- Parents Phase 2, Sess 4: How Do I Start My Plan?
  5. TALC LA- Parents Phase 2, Sess 5: How Can I Really Listen To My Children?
  6. TALC LA- Parents Phase 2, Sess 6: How Can I Tell My Children What I Feel?
  7. TALC LA- Parents Phase 2, Sess 7: How Should I Deal with Problem Behavior?
  8. TALC LA- Parents Phase 2, Sess 8: How Can We Create a Positive Atmosphere at Home?
  9. TALC LA- Parents Phase 2, Sess 9: How Can We Resolve Conflicts at Home? (Part 1)
  10. TALC LA- Parents Phase 2, Sess 10: How Can We Resolve Conflicts at Home? (Part 2)
  11. TALC LA- Parents Phase 2, Sess 11: How Can We Work Together on Selecting a Custodian?
  12. TALC LA- Parents Phase 2, Sess 12: How Can We Deal with Drugs and Alcohol?
  13. TALC LA- Parents Phase 2, Sess 13: How Do I Prevent Pregnancy and Fatherhood?
  14. TALC LA- Parents Phase 2, Sess 14: Where Am I in Making a Custody Plan?
  15. TALC LA- Parents Phase 2, Sess 15: How Can Mothers Encourage Safer Sex?
  16. TALC LA- Parents Phase 2, Sess 16: What is the Mother's Legacy and the Youth's Goals?

 Adolescents’ Curriculum

Phase 3 – Adjustment

New Caregivers and Teens’ Curriculum

  1. TALC LA- New Caregivers and Teens Phase 3, Sess 1: What Do Adolescents and Caregivers/Parents Need from Each Other?
  2. TALC LA- New Caregivers and Teens Phase 3, Sess 3: Dealing with Loss and Grief - Part I
  3. TALC LA- New Caregivers and Teens Phase 3, Sess 4 (Caregivers): Raising an Adolescent
  4. TALC LA- New Caregivers and Teens Phase 3, Sess 4 (Youths): Planning for My Future - Part I
  5. TALC LA- New Caregivers and Teens Phase 3, Sess 5: Dealing with Loss and Grief - Part II
  6. TALC LA- New Caregivers and Teens Phase 3, Sess 6: How Can We Improve Communication - Part I (Effective Expressing)
  7. TALC LA- New Caregivers and Teens Phase 3, Sess 7: Ways of Helping Someone Cope with Loss and Grief
  8. TALC LA- New Caregivers and Teens Phase 3, Sess 8: How Can We Improve Communication - Part II (Active Listening and Responding)
  9. TALC LA- New Caregivers and Teens Phase 3, Sess 9 (Caregivers): Caregiver Support
  10. TALC LA- New Caregivers and Teens Phase 3, Sess 9 (Youths): How Do I Achieve My Goals?
  11. TALC LA- New Caregivers and Teens Phase 3, Sess 10: (Joint) How Can We Deal With Anger in the Relationship?
  12. TALC LA- New Caregivers and Teens Phase 3, Sess 11: How Can I Cope with Sadness?
  13. TALC LA- New Caregivers and Teens Phase 3, Sess 12 (Caregivers): How Should I Deal with Problem Behavior?
  14. TALC LA- New Caregivers and Teens Phase 3, Sess 12 (Youths): How Do I Deal with Fear?
  15. TALC LA- New Caregivers and Teens Phase 3, Sess 13: How Do We Practice Safer Sex, Prevent Pregnancy, and Reduce Alcohol and Drug Use?
  16. TALC LA- New Caregivers and Teens Phase 3, Sess 14: How Can We Resolve Conflicts at Home?
  17. TALC LA- New Caregivers and Teens Phase 3, Sess 15: How Can We Create a Positive Atmosphere at Home?
  18. TALC LA- New Caregivers and Teens Phase 3, Sess 16: Looking to the Future Together, What Can We Do?

Young Adults’ Curriculum

  1. TALC LA- Young Adults Phase 3, Sess 1: How Are Things Going?
  2. TALC LA- Young Adults Phase 3, Sess 2: Planning for My Future - Part I
  3. TALC LA- Young Adults Phase 3, Sess 3: Dealing with Loss and Grief - Part I
  4. TALC- Young Adults Phase 3, Sess 4: Where and How Can Young People Get Support?
  5. TALC LA- Young Adults Phase 3, Sess 5: Dealing with Loss and Grief - Part II
  6. TALC LA- Young Adults Phase 3, Sess 6: Ways of Coping with Loss and Grief
  7. TALC LA- Young Adults Phase 3, Sess 7: Planning for My Future (Part II) - How Do I Achieve My Goals?
  8. TALC LA- Young Adults Phase 3, Sess 8: Hearing and Getting Heard
  9. TALC LA- Young Adults Phase 3, Sess 9: How Can We Deal with Anger?
  10. TALC LA- Young Adults Phase 3, Sess 10: Relationships and Sex (Part 1)
  11. TALC LA- Young Adults Phase 3, Sess 11: Relationships and Sex (Part 2)
  12. TALC LA- Young Adults Phase 3, Sess 12: How Can I Cope with Sadness?
  13. TALC LA- Young Adults Phase 3, Sess 13: Pregnancy and Parenthood
  14. TALC LA- Young Adults Phase 3, Sess 14: How Do I Deal with Fear?
  15. TALC LA- Young Adults Phase 3, Sess 15: How Can I Reduce Substance Use?
  16. TALC LA- Young Adults Phase 3, Sess 16: Looking to the Future

Intervention Model: 

Mothers and their adolescents attended a 16-session cognitive behavioral intervention over eight weeks. For MLH, intervention goals aimed to: 1) improve parenting while ill (i.e., reduce family conflict, improve communication, clarify family roles); 2) reduce mental health symptoms; 3) reduce sexual and drug transmission acts; and 4) increase medical adherence and assertiveness with medical providers. For adolescents, the intervention goals were to: 1) improve family relationships; 2) reduce mental health symptoms; 3) reduce multiple problem behaviors (e.g., drug use, criminal justice acts, school problems, teenage pregnancy); and 4) school retention.

Research Methods:

In a random assignment study, families assigned to take part in Project TALC were compared with families assigned to a control group on mental health and health behaviors, including sexual behavior and substance use. Both intervention and control families were compared to a neighborhood cohort, matched on sociodemographics. Because study participants were followed over two years, longitudinal random effect regression models were used to test the efficacy of the intervention.

Surveys and Scales Used:

  1. Living Situation, Including Neighborhood Problems - Scale
  2. Religion: Attendance and Experience
  3. Financial, Labor, and Educational Experience - Scale
  4. Loss and Grief - Scale
  5. Treatment History - Survey
  6. Social Support - Survey
  7. Romantic Relationships - Survey
  8. Needle Use and Sharing - Survey
  9. Reproductive Health - Survey
  10. Parentification - Survey
  11. Goals Scale
  12. Natural Mentors
  13. Dealing with Mother's Illness - Survey
  14. Acculturation, Habits, and Interests Multicultural Scale for Adolescents (AHIMSA)
  15. Sexually Transmitted Disease - Survey
  16. Medication Adherence - Survey
  17. Educational (Academic) Experience Assessment
  18. Family Functioning - Scale
  19. Family Composition - Scale
  20. Employment and Labor Experience Assessment - Survey
  21. World Health Organization Quality of Life (WHOQOL) - Survey
  22. Self Harm: Suicide History - Survey
  23. CDC Sexual Behavior Questions (CSBQ)
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  25. Detention and Jail History Assessment - Survey
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  27. Alcohol and Other Drug Abuse (AOD) - Scale
  28. Adolescent Substance Use - Survey
  29. PTSD Index for DSM IV (Adolescent version) - UCLA
  30. Parker Parental Bonding Instrument
  31. Positive and Negative Affect Scale (PANAS)
  32. Network Assessment
  33. Janis Self-Esteem - Scale
  34. Medical Outcomes Study (MOS) Social Support - Survey
  35. Living Situation for Adolescents - Survey
  36. Life Outcome Expectancies Assessment - Survey
  37. Life Goals Assessment - Survey
  38. Life Events Assessment - Survey
  39. House Rules - Scale
  40. HIV Related Incidents - Survey
  41. Healthcare Utilization, Providers, and General Health Assessment: Including STD and Pregnancy - Survey
  42. HIV Testing Assessment - Survey
  43. General Medical History Assessment
  44. Multiple Problem Behavior - DSM Conduct Problems (DSMC) - Conduct Disorder
  45. Conflict Resolution - Conflict Tactics Scale (CTS)
  46. Adult Adolescent Parenting Inventory (AAPI) - Survey
  47. Nutrition and Exercise - Survey
  48. Rosenberg Self-Esteem (RSE) - Scale
  49. Dealing with Illness - Scale

Local Significance: 

There was a lack of significant findings for an intervention effect on HIV-transmission behaviors and mental health. HIV-transmission behaviors were low to begin with and participants had little room for improvement. The populations affected by the HIV epidemic in the U.S. have shifted over the past number of years since a similarly mounted intervention in New York City led to improvements. HIV interventions in the U.S. need to shift their focus to persons living with HIV who are experiencing substantial problems.

International Significance:

While the focus of U.S.-based HIV interventions need to shift, interventions for the general HIV population may be effective outside the U.S.

Mamekhaya

In South Africa, where a large portion of pregnant women are HIV positive, prevention of mother-to-child transmission of HIV (PMTCT) is an important endeavor. To improve the effectiveness of the standard PMTCT programs, the Mamekhaya program used peer mentoring and a culturally adapted cognitive behavioral intervention (CBI).
Research Methods:
HIV-positive pregnant women at the Gugulethu Midwife Obstetric Unit and at the Vanguard Community Health Center in Cape Town were invited to participate in the study. Participants at both sites received the standard PMTCT care; however, participants at the Gugulethu site received the Mamekhaya intervention.The first part of the intervention consisted of assigning a participant with a mentor mother through Mothers2mothers. The mentor mother was a woman who was HIV-positive, had recently had a child, and had received PMTCT and was doing well. Participants also attended group sessions of a cognitive-behavioral intervention. The sessions included information on living with HIV, preventing HIV transmission, parenting, social support, and mental health.
Local Significance: 
Participants in the Mamekhaya intervention had increased HIV knowledge scores, significantly increased social support, and significantly decreased depression scores compared to women in the control group.

Rectal Transmission of STIs/HIV among Women

While the prevalence and epidemiology of rectal sexually transmitted infections (STIs) are well characterized among men who have sex with men (MSM), little is known about rectal STIs in women. Evidence demonstrates that women also practice anal intercourse (AI) and are therefore at risk for these infections. The proposed study will investigate contextual factors as well as the prevalence and correlates of rectal STIs among women attending public sexually transmitted disease (STD) clinics in Los Angeles County (LAC) and determine if women who report substance use have differing risks for rectal STIs as compared to women who do not report substance use.

The specific aims of the project are to:
(1) identify contextual factors, which influence AI and the acquisition of rectal C. trachomatis and/or N. gonorrhoeae infection among women, comparing the particular context of substance use;
(2) measure the prevalence and correlates of rectal C. trachomatis and/or N. gonorrhoeae infection among women and determine whether this varies by substance use status.

Unprotected AI is recognized as one of the most efficient modes of HIV sexual transmission and is a commonly practiced behavior with opposite sex partners, with estimates of AI ranging from 7-40% in the United States. It is well established that HIV transmission probabilities are increased in the presence of STIs and there is evidence to suggest that among heterosexuals who report recent AI, about 60-80% report never using condoms suggesting they are likely to also be exposed to other STIs. Although it is clear that AI is a sexual practice with a high probability of transmission of HIV, data on the prevalence and incidence of rectal STIs among women reporting recent anal intercourse is limited. The proposed study will use both qualitative and quantitative methods to examine contextual and individual level factors associated with the acquisition of rectal STIs in women who report AI. Specifically, we will use the Theory of Gender and Power as a framework to examine AI and rectal STI-related exposures and risk factors among women attending the 12 public STD clinics in LAC (Aim 1). We will interview both women who are diagnosed with rectal C. trachomatis or N. gonorrhoeae infection and women who are not diagnosed with these infections, in order to identify key differences, particularly by substance use status. Concurrent to the qualitative assessment we will collect quantitative information available as part of the standard of care within the STD clinics. Currently, all clinics collect demographic and risk behavior information and conduct vaginal screening and rectal screening for C. trachomatis and N. gonorrhoeae among women who report AI. The laboratory testing results, along with medical record information will be used to provide estimates of the prevalence and correlates of rectal STIs and determine the extent to which this varies by substance use status (Aim 2).

The findings from this study will be one of the first to describe the prevalence and factors associated with rectal STIs among a relatively high risk group of women. At the end of the award period, these results will not only help inform overall rectal screening guidelines for women but will be used to develop a proposal designed to test a prevention intervention aimed at reducing the acquisition of rectal STIs/HIV among women.

Healthy Living Project (HLP): Multi-Institutional Collaborative Research Project

The UCLA Healthy Living Project was funded by the National Institute of Mental Health (NIMH) and was designed to promote health-related behavior changes in adults living with HIV. This project aimed to reduce sexual and injection drug use risk behaviors among 1,200 HIV positive men and women in order to decrease the likelihood of secondary HIV transmission. The research study focused on four subgroups: women, heterosexual men, men who have sex with men, and injection drug users. The study was conducted at four sites: Los Angeles, Milwaukee, New York, and San Francisco.

Targeted Risk Group:

Adults living with HIV

Interventions, Training Manuals, etc. : 

Intervention model:

Cognitive behavioral intervention comprised of 15 individually delivered counseling sessions covering three areas: “Stress, Coping, and Adjustment,” “Risk Behaviors,” and “Health Behavior.”

Research Methods: 

In a random assignment study, individuals assigned to take part in the intervention were compared with individuals assigned to a control group, i.e. delayed intervention, on HIV-transmission behaviors, including unprotected sex and substance use. Because participants were followed over two years, longitudinal random effect regression models were used to test the efficacy of the intervention.

Local Significance: 

The intervention was demonstrated to reduce risky sexual behavior and substance use.
At the end of the study, the goal was to train service provider staff to deliver the intervention to their clients. By collaborating with service providers early on in the intervention study, it was possible to learn how to tailor the intervention to the specific needs of the agencies involved and the people they serve.

International Significance: 

HLP provided a behavioral intervention that can be adapted for other countries and cultures to reduce HIV-transmission risk behaviors

Philani- Cape Town

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), img_5313and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Furthermore, while clinics are the typical sites for treating each of these health problems, the NIAAA-funded Philani study is examining a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention encourages mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for the next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Targeted Risk Group:
Mothers at risk for hazardous alcohol use, HIV, TB, and malnutrition, as well as their infants

Published Journal Articles:

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Interventions, Training Manuals, etc: 

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Surveys/Scales Used: 
  1. Tolerance, Worried, Eye-Opener, Amnesia, Cut Down (TWEAK) - Survey
  2. Social Support - Survey
  3. Romantic Relationships - Survey
  4. Reproductive Health - Survey
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  6. Routines
  7. Relationships and Violence - Survey
  8. Household Characteristics and Composition - Survey
  9. AIDS Knowledge and Attitude for Pregnant Women - Survey
  10. Edinburgh Postnatal Depression Score (EPDS)
  11. Alcohol Use Disorders Identification Test (Audit C) - Scale
  12. Feeding Strategies to Prevent Transmission - Survey
  13. Medication Adherence - Survey
  14. Employment and Labor Experience Assessment - Survey
  15. CDC Sexual Behavior Questions (CSBQ)
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  17. Alcohol and Other Drug Abuse (AOD) - Scale
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  19. HIV Testing Assessment - Survey
  20. General Medical History Assessment
  21. General Health Questionnaire

Intervention model:
Mothers who are thriving in the community are chosen to act as role models, i.e. mentor mothers, for mothers at risk in the same community. This is based on the positive peer deviant model. Mentor mothers conduct home visits during the course of the study.

Research Methods:
Twenty four neighborhoods were randomly assigned to the intervention (12 neighborhoods), i.e. a mentor mother home visiting program, or control condition (12 neighborhoods). There are two levels of nesting in the study. Mothers and their infants are nested within neighborhoods, and repeated observations over time are nested within individuals. Longitudinal random effect regression models will be used to account for the nesting and examine the efficacy of the intervention at improving the health of infants and their mothers over time.

Local Significance:
The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention. Preliminary results are promising and suggest the mentor mother program may be an efficient mechanism to conduct healthcare-related home visits.

International Significance:
If found to be efficacious, the home-visiting model that relies on paraprofessionals, i.e. trained mentor mothers, offers a viable alternative to clinic-based healthcare and or care that requires professional healthcare providers that may not be practical in poorer countries outside the U.S.

Masihambisane – Pregnant Women: KZN

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Since clinics are the typical sites for treating each of these health problems, the NIMH-funded Masihambisane study is examining a clinic-based prevention program delivered by neighborhood Mentor Mothers (MM) to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention encourages mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Targeted Risk Group: 

Mothers at risk for hazardous alcohol use, HIV, TB, and malnutrition, as well as their infants

Published Journal Articles :

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Interventions, Training Manuals, etc. :  

Surveys and Scales Used: 

Intervention model:  
In the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program, delivered by HIV-positive mentor mothers. HIV-positive mentor mothers are women who are thriving in the community and who have been through the PMTCT program. They have been recruited and trained to deliver the intervention to pregnant mothers living with HIV.

Research Methods: 

Eight clinics were randomly assigned to the intervention (4 clinics) or control condition (4 clinics). There are two levels of nesting in the study. Mothers and their infants are nested within clinics, and repeated observations over time are nested within individuals. Longitudinal random effect regression models will be used to account for the nesting and examine the efficacy of the intervention at improving the health of infants and their mothers over time.

Local Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

International Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

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