HIV and Its Prevention Amid Brooklyn's Adolescents

HIV Prevention Among Adolescents in Brooklyn

Intervention studies are an approach to health conditions that is being used globally. For any given community, there can be success with intervention studies, or the intervention studies can be insufficient to decrease the effect of health issues upon the community. One medical condition which has been the subject of intervention studies is HIV. While there have been numerous intervention studies of HIV, their result has been both success and failure. In this report, five intervention studies for HIV are reviewed. From these data, a new method to decrease HIV effects upon adolescents in Brooklyn is proposed.

Define HIV

The human immunodeficiency virus (HIV) is a retro-virus that can be passed from one human to another via contact with broken skin, eyes, or vaginal and/or anal tissue (HIV Basics). The process of viral growth includes reproduction, during which structural mutations may occur (HIV Basics). Unfortunately, each of these mutations may include new resistance to drug therapy that was formerly efficacious. Present HIV therapy includes pharmaceutical combinations that function via considerable slowing of the HIV organism's ability to develop resistance (HIV / AIDS)

I. PrEP, Pre-Exposure Prophylaxis

The intent of the PrEP intervention for HIV prevention is to offer those at high risk a daily prophylactic medication. Participants are given Truvada, which is a pharmaceutical combination of emtricitabine and tenofovir, two drugs often used in HIV-treatment. Use of Truvada can aid in prevention of permanent HIV-infection for those at risk due to sexual or drug-use via injection (PrEP).

Even for high-risk individuals, a 92% decrease in HIV-risk has been shown with consistent usage of Truvada and the PrEP intervention / however, failure to take the drug consistently makes it far less effective. While it is known that PrEP can be a powerful weapon in the arsenal against HIV, particularly if combined with condoms and other methods for HIV-prevention, it is only effective with the consent and appropriate behavior of the individual at risk. Basic requirements for the PrEP intervention program include a daily commitment to taking the pharmaceutical as well as an agreement to have a follow-up visit with a health care provider every three months (PrEP).

In the PrEP Intervention Study, participants who took the pill constantly had the lowest HIV infection/transmission risk:

A 49% reduction in risk of HIV-infection was observed for users of injection drugs who took tenofovir once daily (PrEP). A 74% decreased risk of HIV-infection was observed for study participants whose blood levels indicated they were taking tonofovir appropriately (Bangkok Tenofovir Study )

There was a 44% lower probability for those bisexual and gay men given PrEP to become HIV-infected than for those who took a placebo (PrEP). A 92% decrease in risk of HIV-infection was observed for those men who consistently took the pill (iPrEx Study

Comparison of HIV-discordant couples indicated a 75% lower likelihood of infection for those receiving PrEP than for those receiving the placebo (PrEP). As well, PrEP decreased the risk of HIV infection by as much as 90% for those having detectable blood levels of PrEP (Partners PrEP Study )

There was a 62% reduction for HIV-risk for women and men who were heterosexually active and following the PrEP protocols (PrEP). Comparison of participants who became infected with those who did not revealed that the HIV-infected had lower blood levels of the pharmaceutical (TDF2 Study )

No significant evidence of health safety issues, or toxicity, was reported for daily use of the oral PrEP pharmaceutical. Minor side effects such as loss of appetite and/or upset stomach were reported upon initial use of PrEP; however, these generally occurred only during the initial period of usage and generally did not recur (PrEP).

II. Intervention via CHAT

Another HIV-prevention model is called the CHAT Intervention. CHAT consists of one individual 'counseling' session, and five sessions in groups of 4-8 participants. The CHAT model utilizes a philosophy of 'harm reduction' (CHAT Intervention). Peer mentor women are trained in communication methods to discuss HIV and STD risk reduction with family, friends, and sex partners (social network) (CHAT Intervention). The acronym CHAT represents four communication skills taught to participants. These are (a) Choose the correct place and time for the discussion; (b) Hear the other person; (c) Ask questions when possible; and (d) Talk with respect for the other person. The CHAT intervention is intended to enhance risk reduction for the peer mentions as well as the members of their social network (CHAT Intervention).

CHAT Intervention Key Effects

Decreased sexual behavior considered 'risky'

Decreased sexual partners

Decreased sex without protection

CHAT Intervention Goals

Decrease HIV-related drug and/or risky behavior

Increase use of condoms

Enhance communication skills re STD/HIV

Decrease sex partners

Enhance social network understanding of sexual risk reduction

Duration of CHAT Intervention

Three week training consisting of semi-weekly 2-hour sessions for a total of six meetings (CHAT Intervention)

Chat Intervention Method Findings of Significance

At 6 months post-intervention, participants self-reported fewer sexual partners (two or fewer) than self-reporting comparison participants (Adj OR = 0.28, CI = 0.13, 0.63, p

Measured at 18-months post-intervention, participants self-reported significantly fewer incidences of unprotected vaginal sex (Adj OR = 0.47, CI = 0.25, 0.87, p

At both 12 months and 18 months post-intervention, self-reporting by the CHAT intervention participants indicated that they were significantly less likely than comparison participants to have non-protected sex with a person other than their main partner. Data for 12 months: (Adj OR = 0.36, CI = 0.16, 0.84, p

III. Couple-Based HIV Risk Reduction, CONNECT 2

A program of HIV risk reduction intervention for heterosexual couples is called Connect 2. This program specifically works with participants who are drug-involved HIV-negative concordant heterosexual couples. According to CONNECT 2, the HIV-Intervention program can be provided to either the drug-involved member of the couple, or to both members of the couple. The CONNECT 2 intervention focuses on several key issues: a) couple communication; b) problem solving skills; c) training in condom use as well as syringe disinfection skills; d) sexual and drug-risk reduction; e) disclosure and mutual drug-related sexual risks; enhancing mutual protection and motivation; and goal-setting for mutual risk reduction (CONNECT 2).

Key Intervention Effects (CONNECT 2)

• Decreased incidences of unprotected vaginal sex with intervention partner

• Decreased unprotected vaginal sex with any partners

Target Population

High risk concordant heterosexual couples, drug-involved, HIV-negative (CONNECT 2)

Significant Findings

Coupled intervention members, self-reporting at 6 months post-intervention, indicated significantly greater uniform use of condoms in the past 90 days vs. The self-reported condom use of comparison participants, for vaginal sex with either their designated partner (OR = 2.16, 95% CI = 1.29, 3.61, p

Coupled intervention participants, self-reporting at 6 months post-intervention, indicated significantly lower incidence rates in the past 90 days vs. .comparison participants for unprotected acts of vaginal intercourse with their study partner (IRR = 0.70, 95% CI = 0.54,0.92, p

• At 6 months post-intervention, couple-based intervention participants self-reported a significantly lower incidence of unprotected vaginal intercourse in the past 90 days with either their study partner (IRR = 0.70, 95% CI = 0.51, 0.96, p

• At 6 months post-intervention, self-reports by combined intervention participants showed a significantly lower incidence of anal sex without protection across all partners (OR = 0.61, 95% CI = 0.40, 0.95, p

• Comparison of couple-based and individual-level intervention participants at 12 months post-intervention indicated that the couples self-reported significantly lower acts of unprotected vaginal intercourse with their study partner (IRR = 0.59, 95% CI = 0.35, 0.99, p

IV. HLP, HEALTHY LIVING PROJECT

For individuals living with HIV, there is an intervention program called Healthy Living. This program consists of 15 sessions in three modules, delivered one-on-one to the HIV-infected individual. The three modules each have five sessions, designed to focus on and improve quality of life in different broad health areas: sexual, mental, and physical (HLP). Module topics are designed to address and enhance positive strategies for dealing with issues of: complex medication requirements, injection drug use, sexual risk behavior, symptoms of depression and/or anxiety, and overall recognition of behavioral impact on not only the individual themselves but also their partners, families, and friends (HLP). In the first Module (entitled stress, coping, and adjustment), the focus is on psychological coping with the HIV-diagnosis, quality of life, and how to achieve and maintain social relationships that are supportive (HLP). The second Module (entitled safer behaviors) focuses on enhanced self-regulation particularly with respect to drug use and sexual behavior. The third Module (health behaviors) focuses on helping the individual not only to access health services, but also addresses adherence to pharmaceutical prescriptions and medical advice, as well as how to actively participate in any health/medical decision process (HLP). In each case, while the sessions and modules are standardized, there are specific activities designed for intervention participant. Every session also includes cognitive-behavioral techniques -including trigger identification, goal setting, and problem solving - as well as exercises in skills development and psycho-education. The intent is to assist the intervention participant to more effectively meet daily challenges independently (HLP).

Duration of Intervention

• Three modules of five sessions each were established for the total of fifteen 90-minute sessions (HLP). Thus, in a given two-month period, one module was activated, followed by a three-month period until the next module; this pattern was repeated over a one year (twelve month) period (HLP).

Criteria for Eligibility

In order for an individual to be eligible for the program, both women and men were required to provide medical documentation of their HIV-infection status. As well, a minimum age-requirement of 18 years was enforced; freedom from psychosis or serious neuropsychologic impairment was yet another requirement. Participants could not be part of any other HIV-intervention study, and were required to not be currently having unprotected sex (self-report basis) with either an HIV-infected non-primary individual, or with either an unknown serostatus individual or an HIV-negative person (HLP).

Follow-up Time and Measure of Relevant Outcomes

• At five-month intervals from the Intervention onset (5, 10, 15, 20, & 25 months, respectively) each individual was assessed for participation in HIV-risky sexual acts. These were defined as having unprotected receptive or insertive vaginal or anal sex with partners who were either negative for HIV or were of unknown serostatus. The assessments were thus held at roughly three-month intervals after completion of each intervention module, for example, approximately three months after module three, and then again at eight and 13 months after completion of module three (HLP).

In addition, self-reported adherence to medication was examined. This was measured as percentage of prescription ingested over a three-day period. Medication adherence was measured at five, ten, fifteen, twenty, and twenty-five months past the baseline of the study onset. Correlation of self-reported medication adherence with treatment modules was thus approximately 3 months after modules one and three, as well as subsequently at three, eight, and thirteen months after the final module (HLP).

Study Population

The basic HLP study population included 936 HIV-positive women and men defined by the following characteristics (HLP):

Age range 19-67 years, average age 40 years

8% Other, 15% Hispanic, 32% Caucasian, 45% African-American,

21% Female, 79% Male

57% MSM (72% of men are MSM)

Educational level: 81% with at least high school education

Findings of Significance

At 20 months after baseline and eight months subsequent to 3-module completion, participants in Intervention recorded fewer HIV-transmission risk acts than participants in Control, a significant finding (unreported test statistic; p = 0.007) (HLP).

At five to 25 months after baseline, participants in Intervention recorded fewer HIV-transmission risk acts than participants in control, a significant finding (X2 = 16.0; p = 0.007) (HLP).

Comparison of intervention participants and control participants at 3 months after the 3rd module (15 months post-baseline), those participants self-reporting less than 85% adherence at baseline had improved to at least a 10% increased adherence (88.6% versus 78.3%, respectively; F-test = 4.9579, p = 0.027).

Intervention Failure

The HLP intervention study should be considered as a failure, or at the least could be significantly improved. First, because this study did not measure viral load and did not include all data, it fails to meet the best-evidence criteria. Second, a sub-sample of the participants who initially reported less than 85% adherence at the initial interview (baseline) and were still on anti-retroviral therapy (ART) were evaluated for improvement of adherence (HLP). Analysis revealed that this sub-sample had a nearly 13% improved adherence, self-reported, vs. control participants (83.6% versus 70.3%, respectively; p < 0.01) at 5 months post-baseline (3 months after module 1) (HLP). However, because this assessment time period occurred during the intervention modules (HLP), it does not meet efficacy criteria.

It is interesting to note that following Module 1 (Stress, Coping, and Adjustment) there was a higher increase in medication adherence than following Module 3 (Health Behaviors, including medication adherence). The difference was 13% vs. 10%, respectively, but this factor was not analyzed statistically. Perhaps because Module 1 focused on factors that have been equated with HIV-treatment adherence, the contents of Module 1 were useful for the intervention participants in terms of adherence improvement (HLP).

Anti-retro viral (ART) pill usage per day was minimally smaller for intervention participants than for control participants (p = 0.05), although there was no statistical difference for mean baseline adherence (p = 0.54) (HLP).

Small deviations in adherence were self-reported for intervention participants at eight months after module three (twenty months post baseline). As well, there was a small increase in adherence for the intervention participants at thirteen months after module three. Neither of these changes was statistically significant (HLP).

V. STD/HIV Risk-Reduction using Cognitive Behavioral Intervention

Using an individual-level program with multiple components, the Cognitive-Behavioral STD/HIV Risk-Reduction Intervention is focused on prevention of sexually transmitted diseases (STDs) among heterosexual adults at high risk. With an emphasis on a cognitive-behavioral approach to decreasing STD/HIV risk, adults at a public STD clinic were given an opportunity to participate in four intervention sessions, addressing symptoms, transmission, treatment, and types of a variety of STDs (Cognitive Behavioral). Subsequently, patient and counselor have sessions in which alternative behavior, personal triggers, and risk are discussed, and a risk reduction plan is developed for the patient with the counselor's aid. Subsequent meetings are follow-ups to assess how the plan is working, as well as to provide support and feedback for the patient (Cognitive Behavioral). Social support sources, methods for implementing risk-reduction strategies, and guidance on communication with sexual partners are also part of the intervention. Condoms are provided to the participant, as well as practice sessions for condom application. The intervention program uses a variety of methods and media, ranging from role play, vignettes, discussion, video, written materials, and individual counseling to assist the participant to recognize and evaluate their own behavior that places them at risk for STDs and/or HIV-infection. From these intervention methods, it is hoped that the participant will commit to changing the behavior placing them at a health risk, and ultimately use the training in risk reduction to protect themselves and prevent STD/HIV infection (Cognitive Behavioral).